Stryker Corporation
Medical device manufacturer in Selzach, Swit.
352510(k) clearances
2PMA approvals
192recalls
Device types
- HRS Plate, Fixation, Bone 25
- GCJ Laparoscope, General & Plastic Surgery 20
- MAX Intervertebral Fusion Device With Bone… 17
- JEY Plate, Bone 13
- HRX Arthroscope 12
- HSB Rod, Fixation, Intramedullary And Accessories 12
- KTT Appliance, Fixation, Nail/Blade/Plate… 11
- MBI Fastener, Fixation, Nondegradable, Soft… 10
- NKB Thoracolumbosacral Pedicle Screw System 10
- GWO Plate, Cranioplasty, Preformed, Alterable 10
- OLO Orthopedic Stereotaxic Instrument 9
- GEI Electrosurgical, Cutting & Coagulation &… 9
- ERL Drill, Surgical, Ent (Electric Or… 8
- HAW Neurological Stereotaxic Instrument 8
- NDN Cement, Bone, Vertebroplasty 7
- HBE Drills, Burrs, Trephines & Accessories… 7
- KWQ Appliance, Fixation, Spinal Intervertebral… 7
- HWC Screw, Fixation, Bone 6
- OWN Confocal Optical Imaging 6
- FNL Bed, Ac-Powered Adjustable Hospital 5
510(k) clearances (latest 300)
| 510(k) | Device | Decision |
|---|---|---|
| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | 06/29/2026SE |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemHSB · Traditional | 02/03/2026SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | 12/19/2025SE |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemHSB · Traditional | 08/20/2025SE |
| K250163 | T2 Alpha Femur Retrograde Nailing SystemHSB · Traditional | 08/13/2025SE |
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…HRS · Traditional | 10/06/2024SE |
| K233919 | VariAx 2 Distal Radius SystemHRS · Traditional | 03/25/2024SE |
| K233741 | Hoffmann LRF SystemKTT · Special | 12/21/2023SE |
| K230045 | HipCheckQIH · Traditional | 09/29/2023SE |
| K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMOWN · Traditional | 09/20/2023SE |
| K232157 | Connected OR Hub with Device and Voice Control, SDC4K Information Management System with…GCJ · Special | 08/18/2023SE |
| K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…HRS · Traditional | 08/18/2023SE |
| K231257 | Pangea Utility Plating System, Pangea PlatformHRS · Traditional | 08/18/2023SE |
| K230512 | Gamma4 SystemHSB · Traditional | 06/09/2023SE |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®KRO · Traditional | 05/19/2023SE |
| K222381 | PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemHRS · Traditional | 04/27/2023SE |
| K230754 | L12 LED Light Source with AIMOWN · Special | 04/11/2023SE |
| K223772 | PRO Plating System, Stryker Trauma Pelvic Set (Matta)HRS · Traditional | 04/07/2023SE |
| K230605 | 1788 4K Camera System with Advanced Imaging ModalityGCJ · Special | 03/31/2023SE |
| K230216 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)GCJ · Special | 02/23/2023SE |
| K223770 | Sonopet 1Q 3 7cm 1Q LargeLFL · Traditional | 02/16/2023SE |
| K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…HAW · Traditional | 02/16/2023SE |
| K222309 | Gamma4 SystemHSB · Traditional | 11/15/2022SE |
| K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior…KWQ · Traditional | 10/19/2022SE |
| K221074 | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceGEI · Traditional | 09/16/2022SE |
| K222130 | 1688 4K Camera System with Advanced Imaging ModalityGCJ · Special | 08/19/2022SE |
| K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemMEH · Traditional | 08/11/2022SE |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…PGW · Traditional | 07/12/2022SE |
| K221346 | Stryker VariAx 2 MIS CalcaneusHRS · Traditional | 07/08/2022SE |
| K221611 | 780 nm L11 LED Light Source with AIMOWN · Special | 06/29/2022SE |
| K221217 | SPY LaparoscopeGCJ · Traditional | 06/17/2022SE |
| K220319 | Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemHWC · Traditional | 06/10/2022SE |
| K210582 | EasyClip® and EasyClip® XpressJDR · Traditional | 06/10/2022SE |
| K214046 | 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableGCJ · Traditional | 05/25/2022SE |
| K220895 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…GCJ · Special | 04/22/2022SE |
| K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemHSB · Traditional | 02/11/2022SE |
| K213824 | Sonopet iQ Ultrasonic Aspirator SystemLFL · Special | 02/03/2022SE |
| K212581 | VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemHRS · Traditional | 01/19/2022SE |
| K213199 | Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemHWC · Traditional | 01/11/2022SE |
| K212055 | Connected OR Hub with Device and Voice ControlGCJ · Traditional | 12/16/2021SE |
| K212511 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…GCJ · Traditional | 11/04/2021SE |
| K211508 | Steinmann Pins and Kirschner WiresJDW · Traditional | 10/05/2021SE |
| K210861 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…KWS · Traditional | 09/03/2021SE |
| K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…GWG · Traditional | 08/06/2021SE |
| K210377 | Stryker iBur hubs and cutting accessoriesHBE · Traditional | 06/30/2021SE |
| K202964 | iBed Wireless with iBed MobileFNL · Traditional | 06/18/2021SE |
| K211490 | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number…ERL · Special | 06/09/2021SE |
| K210088 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…GCJ · Traditional | 04/13/2021SE |
| K210584 | SDC3 HD Information Management System with Wireless Device Control CapabilityGCJ · Special | 03/18/2021SE |
| K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…HSB · Traditional | 02/26/2021SE |
| K203055 | Stryker PEEK Customized Cranial Implant KitGWO · Traditional | 02/09/2021SE |
| K203568 | Hoffmann LRF SystemKTT · Traditional | 02/01/2021SE |
| K202749 | ADAPT for Gamma3OLO · Traditional | 12/18/2020SE |
| K202289 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…KWS · Traditional | 12/16/2020SE |
| K202659 | Stryker ArthroscopeHRX · Special | 12/01/2020SE |
| K202355 | Stryker Omega PEEK Knotless Anchor SystemMBI · Traditional | 11/13/2020SE |
| K202393 | SpineJack Expansion KitNDN · Traditional | 10/20/2020SE |
| K202609 | Instrument Clamps ElectromagneticPGW · Special | 10/09/2020SE |
| K202592 | Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…GCJ · Special | 10/08/2020SE |
| K201585 | Monterey AL Interbody SystemOVD · Traditional | 08/10/2020SE |
| K201715 | Smart Toe II, X FuseHTY · Traditional | 08/05/2020SE |
| K201434 | Connected OR Hub with Voice Control, Connected OR Hub with Device ControlGCJ · Traditional | 07/28/2020SE |
| K200880 | T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…HSB · Traditional | 07/01/2020SE |
| K200398 | AxSOS 3 AF System and AxSOS 3 Ti SystemHRS · Traditional | 06/05/2020SE |
| K200613 | Tritanium® X TL Expandable Curved Posterior Lumbar CageMAX · Special | 04/15/2020SE |
| K192818 | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemPML · Traditional | 03/31/2020SE |
| K193143 | Stryker Facial iD Plating SystemJEY · Special | 03/26/2020SE |
| K193136 | Stryker Customized Mandible Recon Plate KitJEY · Special | 03/26/2020SE |
| K200493 | Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical…FXY · Traditional | 03/21/2020SE |
| K193366 | T2 IcfHWC · Traditional | 03/20/2020SE |
| K200310 | 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with…GCJ · Special | 03/06/2020SE |
| K200117 | Trevo NXT ProVue RetrieverPOL · Special | 02/07/2020SE |
| K192675 | VariAx FootHRS · Traditional | 11/22/2019SE |
| K192207 | Trevo NXT ProVue RetrieverPOL · Traditional | 11/22/2019SE |
| K192122 | Trevo Trak 21 MicrocatheterDQO · Traditional | 11/22/2019SE |
| K192292 | L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableOWN · Traditional | 11/19/2019SE |
| K192172 | Connected OR Hub with Device and Voice ControlGCJ · Special | 09/09/2019SE |
| K191102 | Precision S 4K SinuscopeEOB · Traditional | 09/06/2019SE |
| K191412 | VariAx 2 System, VariAx 2 Mini Fragment SystemHRS · Traditional | 08/23/2019SE |
| K191259 | Stryker CrossFlow Integrated Arthroscopy PumpHRX · Traditional | 07/12/2019SE |
| K190229 | Stryker PEEK Customized Cranial Implant KitGWO · Traditional | 07/11/2019SE |
| K190696 | Stryker Surgeon iD Mandible Recon PlateJEY · Special | 06/28/2019SE |
| K190779 | Trevo XP ProVue RetrieverPOL · Traditional | 06/25/2019SE |
| K191049 | Stryker MIS and Footed AttachmentsHBE · Traditional | 06/18/2019SE |
| K190172 | Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsHBE · Traditional | 06/14/2019SE |
| K183104 | Mini Cannulated Headed and Headless Screw SetHWC · Traditional | 06/10/2019SE |
| K183381 | Navigation Enabled InstrumentsOLO · Traditional | 05/17/2019SE |
| K191046 | L10 LED Light Source with AIM, L11 LED Light Source with AIMOWN · Special | 05/10/2019SE |
| K190843 | Synchro2 Support GuidewireMOF · Special | 05/01/2019SE |
| K190070 | Sonopet iQ Ultrasonic Aspirator SystemLFL · Traditional | 04/11/2019SE |
| K183464 | AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)NRY · Traditional | 03/13/2019SE |
| K183463 | AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068…DQY · Traditional | 03/13/2019SE |
| K183172 | Stryker SternalPlate SystemHRS · Traditional | 03/05/2019SE |
| K183039 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…KWS · Traditional | 02/15/2019SE |
| K183196 | Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers…OLO · Traditional | 02/14/2019SE |
| K182968 | Hoffmann LRF SystemKTT · Traditional | 01/25/2019SE |
| K183470 | Precision Ideal Eyes ArthroscopesHRX · Special | 01/07/2019SE |
| K182305 | Stryker Facial iD Plating SystemJEY · Traditional | 01/07/2019SE |
| K181752 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon…HRX · Traditional | 12/21/2018SE |
| K182359 | HipCheckLLZ · Traditional | 12/13/2018SE |
| K182160 | 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…GCJ · Traditional | 11/05/2018SE |
| K181258 | ConnectedOR Hub with Device and Voice ControlGCJ · Traditional | 11/05/2018SE |
| K181848 | ADAPT for Gamma3, Gamma3OLO · Traditional | 10/12/2018SE |
| K181091 | AxSOS 3 TiHRS · Traditional | 10/11/2018SE |
| K181742 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…KWS · Traditional | 09/27/2018SE |
| K181504 | Stryker Pediatric Mandibular Distractor 2MQN · Traditional | 09/11/2018SE |
| K181083 | Stryker All-PEEK Knotless Anchor SystemMBI · Traditional | 07/23/2018SE |
| K180500 | VariAx 2 SystemHWC · Traditional | 06/04/2018SE |
| K173946 | ADAPT for Gamma3OLO · Traditional | 05/02/2018SE |
| K173074 | ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorMBI · Special | 04/04/2018SE |
| K172148 | Anchorage Bone Plating SystemHRS · Traditional | 03/19/2018SE |
| K173841 | AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058…NRY · Traditional | 03/18/2018SE |
| K180327 | Stryker iVAS 13g Bone Biopsy KitKNW · Special | 02/26/2018SE |
| K171391 | Stryker 90-S Max SERFAS Energy ProbeGEI · Traditional | 01/26/2018SE |
| K172116 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon…HRX · Traditional | 01/25/2018SE |
| K173866 | Stryker AIM Light Source and SafeLight cableOWN · Special | 01/18/2018SE |
| K173476 | Tritanium® TL Curved Posterior Lumbar CageMAX · Traditional | 01/18/2018SE |
| K172350 | AxSOS 3 TiHRS · Traditional | 12/15/2017SE |
| K173135 | VariAx 2 SystemHWC · Traditional | 11/27/2017SE |
| K172921 | Stryker Self-Punching ICONIXMBI · Traditional | 11/20/2017SE |
| K170725 | Stryker Universal MeshGWO · Traditional | 11/13/2017SE |
| K170773 | Stryker Universal MeshJEY · Traditional | 11/08/2017SE |
| K172572 | Stryker Upper-Face AXS screws and Mid-Face AXS screwsJEY · Special | 10/31/2017SE |
| K172034 | Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock…OLO · Traditional | 10/18/2017SE |
| K172724 | XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryNKB · Special | 10/10/2017SE |
| K172558 | iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy KitKNW · Traditional | 10/05/2017SE |
| K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleERL · Traditional | 09/15/2017SE |
| K171465 | Stryker Self-Punching ICONIXMBI · Traditional | 08/24/2017SE |
| K171364 | MP LeFort I PlatesJEY · Special | 07/24/2017SE |
| K171807 | ES2 Neuromonitoring Accessory InstrumentsPDQ · Special | 07/18/2017SE |
| K170727 | VariAx 2 Compression Plating SystemHRS · Traditional | 06/22/2017SE |
| K170242 | MultiGen 2 RF Generator SystemGXD · Traditional | 05/25/2017SE |
| K171152 | Stryker Universal Neuro III System AXS ScrewHBW · Special | 05/19/2017SE |
| K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryNKB · Traditional | 05/16/2017SE |
| K170771 | VariAx 2 Foot SystemHRS · Traditional | 05/08/2017SE |
| K163656 | Hoffmann LRF SystemKTT · Traditional | 04/14/2017SE |
| K170098 | ICONIX TT All Suture AnchorMBI · Special | 03/31/2017SE |
| K162937 | Stryker OrthoMap Versatile Hip SystemOLO · Traditional | 02/23/2017SE |
| K162929 | Stryker Navigation System with CranialMap software application, Stryker CranialMap…HAW · Traditional | 02/22/2017SE |
| K162841 | VariAx Distal Radius Plating System, VariAx 2 SystemHRS · Traditional | 02/21/2017SE |
| K162439 | AxSOS 3 Ti; Stryker Plating SystemHRS · Traditional | 02/03/2017SE |
| K161514 | Precision Thin Reciprocating Blade, 0.010in.EQJ · Traditional | 01/17/2017SE |
| K161821 | Stryker Universal MeshGWO · Traditional | 12/08/2016SE |
| K161863 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…KWS · Traditional | 11/23/2016SE |
| K161753 | Hoffman LRF SystemKTT · Traditional | 11/15/2016SE |
| K162310 | XBraid TT Suture TapeGAT · Traditional | 11/10/2016SE |
| K162262 | Tritanium® PL CageMAX · Traditional | 11/09/2016SE |
| K162062 | AVAmax Vertebral Balloon, AVAflex Vertebral BalloonHRX · Traditional | 11/01/2016SE |
| K160813 | EasyStepJDR · Traditional | 07/26/2016SE |
| K160955 | Tritanium® PL CageMAX · Traditional | 07/21/2016SE |
| K160978 | LITe BIO Delivery SystemFMF · Traditional | 07/08/2016SE |
| K160715 | AccuLIF TL and PL CageMAX · Traditional | 07/08/2016SE |
| K153379 | AxSOS 3TiHRS · Traditional | 05/26/2016SE |
| K160050 | SERFAS 90-S Electrosurgical ProbeGEI · Traditional | 05/03/2016SE |
| K153407 | Stryker Neptune 3 Waste Management SystemJCX · Traditional | 04/25/2016SE |
| K160693 | Neptune E-SEP Smoke Evacuation PencilGEI · Special | 04/13/2016SE |
| K153377 | Hoffmann LRF (Limb Reconstruction Frame) SystemKTT · Traditional | 04/11/2016SE |
| K151932 | Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use TubingHRX · Traditional | 03/31/2016SE |
| K153248 | PEEK Customized Cranial ImplantGWO · Traditional | 03/10/2016SE |
| K153508 | Stryker CMF MEDPOR Customized ImplantFWP · Traditional | 02/05/2016SE |
| K153679 | Stryker Neptune E-SEP Smoke Evacuation PencilGEI · Special | 01/22/2016SE |
| K151726 | AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…MAX · Traditional | 01/20/2016SE |
| K152651 | AccuLIF TL and PL CageMAX · Traditional | 12/15/2015SE |
| K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryNKB · Traditional | 12/02/2015SE |
| K152641 | Pi Drive Plus Motor, ExtenderERL · Special | 11/20/2015SE |
| K152304 | Tritanium PL CageMAX · Traditional | 11/19/2015SE |
| K151667 | AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter…DQY · Traditional | 11/13/2015SE |
| K151769 | Anchorage 2 CP SystemHRS · Traditional | 10/27/2015SE |
| K143661 | DirectInjectGXP · Traditional | 09/02/2015SE |
| K152076 | PEEK Customized Cranial Implant, PEEK Customized Cranial Implant PriorityGWO · Special | 08/26/2015SE |
| K150584 | Stryker Suture TapeGAT · Traditional | 08/13/2015SE |
| K151879 | VariAx 2 One-Third Tubular Plating SystemHRS · Special | 08/06/2015SE |
| K150700 | ACP 1 Anterior Cervical Plating SystemKWQ · Traditional | 07/15/2015SE |
| K151755 | OASYS(r) SystemNKG · Traditional | 07/09/2015SE |
| K151201 | Stryker ICONIX with NeedlesMBI · Traditional | 06/29/2015SE |
| K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeHBW · Special | 06/24/2015SE |
| K150582 | Vertaplex® High Viscosity (HV) Radiopaque Bone CementNDN · Traditional | 06/12/2015SE |
| K150753 | OASYS SystemKWP · Traditional | 06/09/2015SE |
| K150801 | Stryker Maestro Air MotorsHBB · Special | 05/22/2015SE |
| K150539 | OASYS SystemNKG · Traditional | 05/12/2015SE |
| K143399 | Stryker Footed Attachments and Cutting AccessoriesHBE · Traditional | 05/08/2015SE |
| K142568 | Stryker MEDPOR TITAN 3D Orbital Floor ImplantJEY · Traditional | 05/05/2015SE |
| K143540 | Stryker MIS Attachments and Cutting AccessoriesHBE · Traditional | 05/01/2015SE |
| K143320 | Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsHBE · Traditional | 04/23/2015SE |
| K143173 | Stryker CMF MEDPOR Customized ImplantFWP · Traditional | 03/23/2015SE |
| K150449 | LITe Plate SystemKWQ · Special | 03/20/2015SE |
| K143546 | Imbibe Aspirating XIA TapsKNW · Traditional | 03/19/2015SE |
| K143616 | AccuLIF TL and PL CageMAX · Traditional | 03/05/2015SE |
| K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…OVD · Traditional | 01/26/2015SE |
| K142237 | Aviator Anterior Cervical Plate (ACP) SystemKWQ · Traditional | 01/26/2015SE |
| K142741 | OASYS SystemKWP · Traditional | 01/15/2015SE |
| K142699 | LITe Plate SystemKWQ · Traditional | 12/31/2014SE |
| K142251 | AVS AS PEEK SpacerODP · Traditional | 11/19/2014SE |
| K142066 | Aero-Ll Lumbar Cage SystemOVD · Traditional | 11/13/2014SE |
| K142114 | Xia® Growth Rod Conversion SetPGM · Traditional | 10/27/2014SE |
| K142381 | Xia 3 Spinal SystemNKB · Traditional | 10/21/2014SE |
| K141935 | Stryker S2 DrillERL · Special | 09/26/2014SE |
| K141673 | Ivas 8 Gauge Bone Biopsy KitKNW · Special | 09/04/2014SE |
| K141095 | Stryker Steri-Shield Flyte Hybrid TogasFYA · Special | 08/26/2014SE |
| K133461 | Stryker Universal Orbital Floor SystemJEY · Traditional | 08/01/2014SE |
| K141217 | Acculif TL and PL CageMAX · Special | 07/16/2014SE |
| K140400 | ES2 Neuromonitoring Accessory InstrumentsETN · Traditional | 07/01/2014SE |
| K140588 | Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway LensFXY · Special | 06/26/2014SE |
| K133328 | Aero-Al Lumbar Cage SystemOVD · Traditional | 05/30/2014SE |
| K140095 | Prime Zoom StretcherINK · Traditional | 05/20/2014SE |
| K133285 | Stryker Temporary Condylar ProsthesisNEI · Traditional | 04/09/2014SE |
| K133398 | Stryker Pediatric Mandible DistractorMQN · Traditional | 03/20/2014SE |
| K121664 | T4/T5 Hytrel TogasFYA · Traditional | 03/10/2014SE |
| K133671 | Iconix All Suture AnchorsMBI · Traditional | 02/28/2014SE |
| K121235 | Leibinger Advance Internal Midface Distraction SystemJEY · Traditional | 01/09/2014SE |
| K132671 | Stryker Neptune 2 Waste Managment SystemJCX · Traditional | 12/20/2013SE |
| K132519 | Stryker Customized Mandible Recon Plate KitJEY · Traditional | 12/06/2013SE |
| K131775 | Universal Neuro 3 SystemGWO · Traditional | 10/17/2013SE |
| K130430 | Ivas 10MM and 15MM Balloon CatheterHRX · Special | 05/23/2013SE |
| K123486 | Triathlon Tritanium Tibial BaseplateMBH · Traditional | 05/03/2013SE |
| K123786 | Stryker Universal Orbital Floor SystemJEY · Traditional | 04/09/2013SE |
| K123942 | Stryker Ivas Balloon CatheterNDN · Traditional | 04/03/2013SE |
| K122113 | Memory Metal Staples, EasyclipJDR · Traditional | 03/12/2013SE |
| K123452 | TRACKER-17 Microcather, 150 CM Long and 15.0 CM Flexible Distal Shaft, TRACKER-17…DQY · Special | 01/03/2013SE |
| K122313 | Stryker Universal Smartlock Hybrid MMF SystemJEY · Traditional | 10/31/2012SE |
| K122284 | Hoffmann 3KTT · Traditional | 10/24/2012SE |
| K122053 | Shapematch Cutting GuideMBH · Traditional | 10/24/2012SE |
| K121153 | PEEK Customized Craial Implant KitGWO · Traditional | 09/14/2012SE |
| K120509 | Stryker All Suture AnchorsMBI · Traditional | 07/26/2012SE |
| K121252 | Hoffmann 3 Modular External Fixation SystemKTT · Traditional | 07/25/2012SE |
| K120824 | 3.9MM Reelx STT Suture Anchor SystemMBI · Traditional | 07/18/2012SE |
| K121342 | Xia 4.5 Spinal SystemNKB · Traditional | 06/22/2012SESU |
| K120352 | Stryker Quikflap Sterile Procedure PackGWO · Special | 06/11/2012SE |
| K112593 | Styker Consolidated Operating Room Equipment (Core) SystemERL · Traditional | 05/01/2012SE |
| K120816 | Inzone Detachment SystemKRD · Special | 04/17/2012SE |
| K113327 | Hoffmann LRF (Limb Reconstruction Frame) SystemKTT · Traditional | 03/29/2012SE |
| K120434 | Power Adaptor Instrument AccessoryNKB · Special | 03/08/2012SE |
| K111786 | Hoffmann 3 Modular External Fixation SystemKTT · Traditional | 01/26/2012SE |
| K113154 | Ivas Balloon CatheterNDN · Traditional | 01/24/2012SE |
| K112557 | Stryker Universal Neuro 3 SystemGWO · Traditional | 01/05/2012SE |
| K113109 | Stryker Resorbable Fixation SystemHRS · Special | 12/23/2011SE |
| K112926 | Axsos Locking Plate SystemHRS · Traditional | 12/19/2011SE |
| K111848 | Exeter X3 Rimfit Acetabular CupJDI · Traditional | 10/05/2011SE |
| K112059 | T2 Femoral Nail Model 1825-XXXXCP, 1828-XXXXCPHSB · Special | 08/08/2011SE |
| K111478 | Stryker Spine Power Adaptor (Accessory Instrument)NKB · Special | 08/04/2011SE |
| K103807 | Ivas 2-10MM (10 Guage) Ballon CatheterNDN · Traditional | 06/28/2011SE |
| K110807 | Abg II Monolithic Hip StemMAY · Traditional | 05/25/2011SE |
| K110533 | Stryker Patient Specific Cutting GuideMBH · Traditional | 05/19/2011SE |
| K110476 | Axsos (TM) Locking Plate SystemHRS · Special | 03/18/2011SE |
| K103479 | Novel Tapered Hip StemMEH · Traditional | 03/10/2011SE |
| K103400 | Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipOLO · Traditional | 03/07/2011SE |
| K103292 | Trio Trauma Spinal SystemNKB · Traditional | 03/04/2011SE |
| K102885 | Hoffmann II External Fixation System Line Extension Model 4920-1-010, 4920-1-020…JEC · Special | 01/14/2011SE |
| K103536 | Ibed Wireless with Ibed AwarenessFNL · Traditional | 12/16/2010SE |
| K103124 | Series II X3 Large Diameter Accetabular InsertsLPH · Special | 11/19/2010SE |
| K093206 | Orthomap 3D 1.1 ModuleOLO · Traditional | 08/04/2010SE |
| K093864 | Avs Align PEEK Spacers Model 48328XXX, 48326XXXMAX · Special | 03/11/2010SE |
| K093704 | Avs PL PEEK SpacersMAX · Special | 12/23/2009SE |
| K091606 | Vertaplex HV (Single Pack and Dual Pack)NDN · Traditional | 10/23/2009SE |
| K090816 | Stryker Spine Avs PL PEEK SpacersMAX · Special | 04/24/2009SE |
| K090166 | Avs Anterior Large PEEK SpacersMAX · Traditional | 04/22/2009SE |
| K083020 | Stryker Spine Reflex Translational Anterior Cervical Plating SystemKWQ · Special | 03/26/2009SE |
| K083562 | Stryker Spine Nulock Anterior Cervical Plating SystemKWQ · Traditional | 03/25/2009SE |
| K083661 | Avs TL PEEK SpacersMAX · Traditional | 02/27/2009SE |
| K082813 | Stryker LED LightsourceFCW · Traditional | 12/19/2008SE |
| K080052 | Stryker Essx with Navigation MountERL · Traditional | 10/02/2008SE |
| K082014 | Stryker Spine Avs PL PEEK SpacersMAX · Special | 07/28/2008SE |
| K080450 | Stryker Power Tool Navigator AttachmentHAW · Traditional | 07/17/2008SE |
| K080758 | Avs PL PEEK Spacers, Models 48351 and 48353MAX · Special | 03/27/2008SE |
| K072271 | Stryker Navigation System Infinitus Hip Resurfacing ModuleHAW · Traditional | 12/18/2007SE |
| K072118 | Stryker Vertaplex Radiopaque Bone CementNDN · Traditional | 12/07/2007SE |
| K073151 | Mantis Spinal SystemNKB · Special | 12/06/2007SE |
| K063480 | Stryker RF Intradiscal Adaptor, Model 406-750GEI · Traditional | 05/22/2007SE |
| K070368 | Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemNKB · Traditional | 05/04/2007SE |
| K061108 | Stryker Auto Irrigation SystemFRN · Traditional | 02/02/2007SE |
| K061548 | Stryker Ureteral Illumination System IVFCS · Traditional | 09/28/2006SE |
| K060763 | Stryker Injectable CementGXP · Traditional | 09/22/2006SE |
| K061225 | Stryker Disposable Laparoscopic ScissorsGEI · Traditional | 09/14/2006SE |
| K060061 | Stryker Injectable CementMQV · Traditional | 03/01/2006SE |
| K042405 | PAINPUMP1; PAINPUMP2FRN · Traditional | 10/14/2004SE |
| K041754 | Stryker Maestro SystemHBB · Traditional | 09/07/2004SE |
| K032945 | Simplex XLOD · Traditional | 05/25/2004SE |
| K040764 | Stryker T4 Hytrel Zipper TogaFYA · Special | 04/27/2004SE |
| K033232 | Colorado Microdissection NeedleGEI · Traditional | 02/25/2004SE |
| K032943 | Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy KitsKNW · Traditional | 12/17/2003SE |
| K022309 | Stryker Powered Wheeled StretcherINK · Traditional | 11/08/2002SE |
| K014091 | Stryker PainpumpFRN · Special | 12/31/2001SE |
| K010204 | Stryker Navigation System-Knee ModuleHAW · Traditional | 08/31/2001SE |
| K011755 | Stryker T4 Hytrel (R) TogasLYU · Special | 06/22/2001SE |
| K003792 | Stryker Heated Insufflator Tube SetHIF · Traditional | 02/21/2001SE |
| K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiLOD · Traditional | 01/26/2001SE |
| K002732 | Stryker Navigation System - ENT ModuleHAW · Traditional | 10/02/2000SE |
| K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXHAW · Traditional | 01/18/2000SE |
| K991706 | Virtuoso-Stereotaxic Planning SoftwareHAW · Traditional | 12/07/1999SE |
| K993583 | Zurich Titanium Ossicular Replacement SystemETA · Traditional | 11/10/1999SE |
| K962755 | Stryker Encore SterilizerFLE · Traditional | 03/04/1997SE |
| K954690 | Stryker Oral Max SystemDZI · Traditional | 08/20/1996SE |
| K961970 | Command 2 Micoelectric Surgical SystemHWE · Traditional | 07/26/1996SE |
| K961101 | Stryker Cement Removal SystemLZV · Traditional | 07/15/1996SE |
| K960012 | Stryker Adel BassinetFMS · Traditional | 03/25/1996SE |
| K955599 | Stryker Femoral Canal Sponge & Acetabulum SpongeGDY · Traditional | 02/22/1996SE |
| K950889 | Adel 5000HDD · Traditional | 10/16/1995SE |
| K944393 | Stryker Steri-Shield Surgical ApparelFYA · Traditional | 08/28/1995SE |
| K950824 | Stryker Drop Applicator, Kits, Spray Applicator Kit, TipsFMF · Traditional | 08/25/1995SE |
| K943541 | 75K Staight DrillHBE · Traditional | 05/18/1995SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2833-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 07/01/2026Open, Classified |
| Z-2832-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 07/01/2026Open, Classified |
| Z-2831-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 07/01/2026Open, Classified |
| Z-2830-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 07/01/2026Open, Classified |
| Z-2829-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 07/01/2026Open, Classified |
| Z-2828-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 07/01/2026Open, Classified |
| Z-2827-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 07/01/2026Open, Classified |
| Z-2866-2026 Class II | STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | 06/08/2026Open, Classified |
| Z-2865-2026 Class II | STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | 06/08/2026Open, Classified |
| Z-2864-2026 Class II | STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | 06/08/2026Open, Classified |
| Z-2863-2026 Class II | STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | 06/08/2026Open, Classified |
| Z-2862-2026 Class II | STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | 06/08/2026Open, Classified |
| Z-2282-2026 Class II | Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune…It has been identified that the impacted docking station (SN 2521008873) was not product released from… | 05/06/2026Open, Classified |
| Z-2166-2026 Class II | Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The…Due to nonconforming products being inadvertently distributed. | 04/09/2026Open, Classified |
| Z-1427-2026 Class II | MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and…Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized… | 01/21/2026Open, Classified |
| Z-0601-2026 Class II | NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook -…Tape used to secure components within packaging contains latex, despite products being labeled as… | 10/31/2025Open, Classified |
| Z-0600-2026 Class II | NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product…Tape used to secure components within packaging contains latex, despite products being labeled as… | 10/31/2025Open, Classified |
| Z-0599-2026 Class II | NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13…Tape used to secure components within packaging contains latex, despite products being labeled as… | 10/31/2025Open, Classified |
| Z-2277-2025 Class II | Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK…Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may… | 07/02/2025Open, Classified |
| Z-2171-2025 Class II | Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable TipDue to complaints their is the potential that irrigation solution may leaked into the handpiece and battery… | 06/18/2025Open, Classified |
| Z-2170-2025 Class II | Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without…Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery… | 06/18/2025Open, Classified |
| Z-1914-2025 Class II | Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number:…Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail. | 05/28/2025Open, Classified |
| Z-1940-2025 Class II | Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version… | 05/22/2025Open, Classified |
| Z-1939-2025 Class II | Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version… | 05/22/2025Open, Classified |
| Z-1621-2025 Class II | Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument… | 03/28/2025Open, Classified |
| Z-1620-2025 Class II | Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument… | 03/28/2025Open, Classified |
| Z-1482-2025 Class II | Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208SThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1481-2025 Class II | Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1480-2025 Class II | Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1479-2025 Class II | Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1478-2025 Class II | Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1477-2025 Class II | Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1476-2025 Class II | Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1475-2025 Class II | Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1474-2025 Class II | Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1473-2025 Class II | Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1472-2025 Class II | Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1471-2025 Class II | Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1470-2025 Class II | Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1469-2025 Class II | Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1328-2025 Class II | Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile…Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in… | 01/29/2025Open, Classified |
| Z-1139-2025 Class II | stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal…Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them… | 01/08/2025Open, Classified |
| Z-1138-2025 Class II | stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal…Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them… | 01/08/2025Open, Classified |
| Z-0807-2025 Class II | 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V…Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the… | 12/03/2024Open, Classified |
| Z-0370-2025 Class II | Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile -…There is a potential for the product to activate without manual input when plugged into a power source or… | 10/04/2024Open, Classified |
| Z-0369-2025 Class II | Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button -…There is a potential for the product to activate without manual input when plugged into a power source or… | 10/04/2024Open, Classified |
| Z-0368-2025 Class II | Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch…There is a potential for the product to activate without manual input when plugged into a power source or… | 10/04/2024Open, Classified |
| Z-0367-2025 Class II | Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm -…There is a potential for the product to activate without manual input when plugged into a power source or… | 10/04/2024Open, Classified |
| Z-0366-2025 Class II | Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile -…There is a potential for the product to activate without manual input when plugged into a power source or… | 10/04/2024Open, Classified |
| Z-0365-2025 Class II | Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed…There is a potential for the product to activate without manual input when plugged into a power source or… | 10/04/2024Open, Classified |
| Z-0063-2025 Class II | 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming…May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin… | 09/05/2024Open, Classified |
| Z-2731-2024 Class II | Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | 07/24/2024Completed |
| Z-2730-2024 Class II | Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | 07/24/2024Completed |
| Z-2729-2024 Class II | Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | 07/24/2024Completed |
| Z-2728-2024 Class II | Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | 07/24/2024Completed |
| Z-2727-2024 Class II | Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | 07/24/2024Completed |
| Z-2726-2024 Class II | Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | 07/24/2024Completed |
| Z-2725-2024 Class II | Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | 07/24/2024Completed |
| Z-2724-2024 Class II | Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | 07/24/2024Completed |
| Z-2723-2024 Class II | Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | 07/24/2024Completed |
| Z-2722-2024 Class II | Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following…Potential for the product to exhibit temperatures higher than specification where the bur shank meets the… | 07/24/2024Completed |
| Z-2261-2024 Class II | This product is a single use sterile device that is used to direct the lesion to the…Expired Products distributed to customers | 06/03/2024Open, Classified |
| Z-2260-2024 Class II | Curved, super elastic cement delivery needle that passes through the cannula in a…Expired Products distributed to customers | 06/03/2024Open, Classified |
| Z-2259-2024 Class II | The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be…Expired Products distributed to customers | 06/03/2024Open, Classified |
| Z-2219-2024 Class II | Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.The adjustment ring on the device may become loose resulting in the wire tension not being able to be set… | 05/09/2024Open, Classified |
| Z-1085-2024 Class II | Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cmThe microcatheter IFU contains an intended use that has not been evaluated by the FDA. | 12/06/2023Open, Classified |
| Z-1084-2024 Class II | Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cmThe microcatheter IFU contains an intended use that has not been evaluated by the FDA. | 12/06/2023Open, Classified |
| Z-0287-2024 Class II | Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler…Expired product distributed | 09/13/2023Open, Classified |
| Z-0257-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0256-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0255-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0254-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0253-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0252-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0251-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0250-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0249-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0248-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0247-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0246-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0245-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0244-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0243-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0242-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0241-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0240-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-0239-2024 Class II | Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog…An error was identified on the expiration date of the product label. The shelf life for the products… | 09/11/2023Open, Classified |
| Z-2645-2023 Class II | Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462Expired Product distributed | 08/23/2023Open, Classified |
| Z-2602-2023 Class II | Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle…Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to… | 08/07/2023Open, Classified |
| Z-2601-2023 Class II | Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle…Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to… | 08/07/2023Open, Classified |
| Z-2600-2023 Class II | Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox.…Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to… | 08/07/2023Open, Classified |
| Z-2599-2023 Class II | Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid…Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to… | 08/07/2023Open, Classified |
| Z-2598-2023 Class II | Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows…Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to… | 08/07/2023Open, Classified |
| Z-2597-2023 Class II | Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral…Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to… | 08/07/2023Open, Classified |
| Z-2596-2023 Class II | Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user…Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to… | 08/07/2023Open, Classified |
| Z-2463-2023 Class II | SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting…Potential for current software to miscount when scanning in multiple sponge-products from the same unique… | 07/10/2023Open, Classified |
| Z-0982-2025 Class II | stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone…There is potential the device inside the package may not match the product information on the outer label… | 06/28/2023Open, Classified |
| Z-0981-2025 Class II | stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement…There is potential the device inside the package may not match the product information on the outer label… | 06/28/2023Open, Classified |
| Z-0980-2025 Class II | The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut…There is potential the device inside the package may not match the product information on the outer label… | 06/28/2023Open, Classified |
| Z-1474-2023 Class II | SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X…Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which… | 03/02/2023Open, Classified |
| Z-1344-2023 Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK…Not able to achieve desired pressure and not holding pressure result from two different causes which have… | 03/01/2023Open, Classified |
| Z-1343-2023 Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK…Not able to achieve desired pressure and not holding pressure result from two different causes which have… | 03/01/2023Open, Classified |
| Z-1342-2023 Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK…Not able to achieve desired pressure and not holding pressure result from two different causes which have… | 03/01/2023Open, Classified |
| Z-1341-2023 Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK…Not able to achieve desired pressure and not holding pressure result from two different causes which have… | 03/01/2023Open, Classified |
| Z-1340-2023 Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK…Not able to achieve desired pressure and not holding pressure result from two different causes which have… | 03/01/2023Open, Classified |
| Z-1339-2023 Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK…Not able to achieve desired pressure and not holding pressure result from two different causes which have… | 03/01/2023Open, Classified |
| Z-1191-2023 Class II | stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external…Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts.… | 02/07/2023Open, Classified |
| Z-1186-2023 Class II | Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of…Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate… | 01/25/2023Open, Classified |
| Z-1185-2023 Class II | Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog…Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate… | 01/25/2023Open, Classified |
| Z-1184-2023 Class II | Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog…Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate… | 01/25/2023Open, Classified |
| Z-1011-2022 Class II | Smart Toe II Intramedullary Arthrodesis ImplantThe nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the… | 03/28/2022Open, Classified |
| Z-0728-2022 Class II | 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy…A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down… | 01/14/2022Open, Classified |
| Z-2171-2021 Class II | Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI Elast. Sleeve 8-11), Catalog…The devices have a different inner diameter than the diameter specified on the outer box label. | 05/27/2021Open, Classified |
| Z-2170-2021 Class II | Nail Insertion Sleeve, elastic T2 Tibia SPI 8-13 (SPI Elast. Sleeve 8-13), Catalog…The devices have a different inner diameter than the diameter specified on the outer box label. | 05/27/2021Open, Classified |
| Z-1428-2021 Class II | Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical…Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended… | 02/26/2021Terminated |
| Z-0457-2021 Class II | Osteosynthesis Compression Staple EasyClipThe device has the potential to release nickel above the acceptable margin of safety in pediatric patients… | 09/25/2020Open, Classified |
| Z-2387-2020 Class II | Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker…Seal integrity of the blister pack may be compromised and sterility cannot be assured | 05/07/2020Terminated |
| Z-2386-2020 Class II | Stryker Locking Screw, Fully Threaded T2 Tibia 5x50 mm Catalog Number: 18965050S -…Seal integrity of the blister pack may be compromised and sterility cannot be assured | 05/07/2020Terminated |
| Z-2385-2020 Class II | Stryker Locking Screw, Fully Threaded T2 Tibia 5x45 mm Catalog Number: 18965045S -…Seal integrity of the blister pack may be compromised and sterility cannot be assured | 05/07/2020Terminated |
| Z-2384-2020 Class II | Stryker Locking Screw, Fully Threaded T2 Tibia 5x40 mm Catalog Number: 18965040S -…Seal integrity of the blister pack may be compromised and sterility cannot be assured | 05/07/2020Terminated |
| Z-2383-2020 Class II | Stryker Locking Screw, Fully Threaded T2 Tibia 5x37,5 mm Catalog Number: 18965037S -…Seal integrity of the blister pack may be compromised and sterility cannot be assured | 05/07/2020Terminated |
| Z-2382-2020 Class II | Stryker Locking Screw, Fully Threaded T2 Tibia 5x35 mm Catalog Number: 18965035S -…Seal integrity of the blister pack may be compromised and sterility cannot be assured | 05/07/2020Terminated |
| Z-2381-2020 Class II | Stryker Locking Screw, Fully Threaded T2 Tibia 5x30 mm Catalog Number: 18965030S -…Seal integrity of the blister pack may be compromised and sterility cannot be assured | 05/07/2020Terminated |
| Z-2380-2020 Class II | Stryker Locking Screw, Fully Threaded T2 Humerus 4x32 mm Catalog Number: 18964032S -…Seal integrity of the blister pack may be compromised and sterility cannot be assured | 05/07/2020Terminated |
| Z-2379-2020 Class II | Stryker Locking Screw, Partially Threaded T2 Tibia 5x55 mm Catalog Number: 18915055S -…Seal integrity of the blister pack may be compromised and sterility cannot be assured | 05/07/2020Terminated |
| Z-2378-2020 Class II | Stryker End Cap T2 Humerus 6mm, 15mm height Catalog Number: 18300015S - Product Usage:…Seal integrity of the blister pack may be compromised and sterility cannot be assured | 05/07/2020Terminated |
| Z-2377-2020 Class II | Stryker 1 End Cap T2 Humerus 6mm, 5mm height Catalog Number: 18300005S - Product Usage:…Seal integrity of the blister pack may be compromised and sterility cannot be assured | 05/07/2020Terminated |
| Z-2376-2020 Class II | Stryker End Cap, Standard T2 Humerus 6 mm Catalog Number: 18300003S - Product Usage:…Seal integrity of the blister pack may be compromised and sterility cannot be assured | 05/07/2020Terminated |
| Z-2375-2020 Class II | Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker…Seal integrity of the blister pack may be compromised and sterility cannot be assured | 05/07/2020Terminated |
| Z-2374-2020 Class II | Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage:…Seal integrity of the blister pack may be compromised and sterility cannot be assured | 05/07/2020Terminated |
| Z-2373-2020 Class II | Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product…Seal integrity of the blister pack may be compromised and sterility cannot be assured | 05/07/2020Terminated |
| Z-1926-2020 Class II | Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI:…Sterile drapes packaged in an unsealed pouch. | 01/07/2020Open, Classified |
| Z-1925-2020 Class II | Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI:…Sterile drapes packaged in an unsealed pouch. | 01/07/2020Open, Classified |
| Z-0780-2020 Class II | Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System…Instrument can break at the level of the thread when being exposed to high forces during nail implantation… | 12/05/2019Terminated |
| Z-0781-2020 Class II | Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod…Pin To Rod Coupling could not clamp the pin and rod as intended | 11/21/2019Terminated |
| Z-1509-2020 Class II | Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX…Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the… | 09/12/2019Terminated |
| Z-1508-2020 Class II | Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX…Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the… | 09/12/2019Terminated |
| Z-2424-2019 Class II | Endintrak 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is designed for…The seal integrity of the sterile bag containing the kits may be compromised. | 07/25/2019Terminated |
| Z-2423-2019 Class II | Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed…The seal integrity of the sterile bag containing the kits may be compromised. | 07/25/2019Terminated |
| Z-2422-2019 Class II | Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system is…The seal integrity of the sterile bag containing the kits may be compromised. | 07/25/2019Terminated |
| Z-2421-2019 Class II | Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 The EPF system is designed for…The seal integrity of the sterile bag containing the kits may be compromised. | 07/25/2019Terminated |
| Z-2420-2019 Class II | Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-1 The EPF system is designed…The seal integrity of the sterile bag containing the kits may be compromised. | 07/25/2019Terminated |
| Z-2419-2019 Class II | Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed for the…The seal integrity of the sterile bag containing the kits may be compromised. | 07/25/2019Terminated |
| Z-2418-2019 Class II | Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the…The seal integrity of the sterile bag containing the kits may be compromised. | 07/25/2019Terminated |
| Z-2417-2019 Class II | Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for…The seal integrity of the sterile bag containing the kits may be compromised. | 07/25/2019Terminated |
| Z-2416-2019 Class II | Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the…The seal integrity of the sterile bag containing the kits may be compromised. | 07/25/2019Terminated |
| Z-2415-2019 Class II | Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designed for the…The seal integrity of the sterile bag containing the kits may be compromised. | 07/25/2019Terminated |
| Z-2414-2019 Class II | Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is designed for the…The seal integrity of the sterile bag containing the kits may be compromised. | 07/25/2019Terminated |
| Z-2413-2019 Class II | Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for the…The seal integrity of the sterile bag containing the kits may be compromised. | 07/25/2019Terminated |
| Z-2412-2019 Class II | Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the…The seal integrity of the sterile bag containing the kits may be compromised. | 07/25/2019Terminated |
| Z-1148-2020 Class II | Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI…Complaints have been received regarding difficulty in removing the driver from the screw. High driver… | 07/19/2019Terminated |
| Z-1147-2020 Class II | Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472…Complaints have been received regarding difficulty in removing the driver from the screw. High driver… | 07/19/2019Terminated |
| Z-1849-2019 Class II | Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1The seal integrity of the sterile bag containing the kits may be compromised. | 04/30/2019Terminated |
| Z-1848-2019 Class II | Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1The seal integrity of the sterile bag containing the kits may be compromised. | 04/30/2019Terminated |
| Z-1445-2020 Class II | Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for:…There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not attaching… | 04/23/2019Terminated |
| Z-1728-2019 Class II | Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an…The heated tube sets were consistently leaking and detaching from the cassette. | 03/07/2019Terminated |
| Z-1727-2019 Class II | Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an…The heated tube sets were consistently leaking and detaching from the cassette. | 03/07/2019Terminated |
| Z-1726-2019 Class II | Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High…The heated tube sets were consistently leaking and detaching from the cassette. | 03/07/2019Terminated |
| Z-0980-2019 Class II | Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee ArthroplastyThe faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set. | 01/21/2019Terminated |
| Z-0291-2019 Class II | Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product…The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet… | 08/28/2018Terminated |
| Z-0290-2019 Class II | Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product…The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet… | 08/28/2018Terminated |
| Z-0289-2019 Class II | Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product…The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet… | 08/28/2018Terminated |
| Z-0288-2019 Class II | Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product…The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet… | 08/28/2018Terminated |
| Z-3240-2018 Class II | Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF…When creating a correction plan with the Correct Axial First button selected and the No. of corrections per… | 07/26/2018Terminated |
| Z-2884-2018 Class II | Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE…Incomplete seal on the Tyvek lid may compromise the sterility of the device | 06/27/2018Terminated |
| Z-2244-2018 Class II | Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463Laser etching which indicates whether the device is in compression or distraction mode appears to be on the… | 05/04/2018Terminated |
| Z-2408-2018 Class II | Ankle Arthrodesis Nail, right T2 Ankle 11x300mm, Product Number 18191130SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2407-2018 Class II | Ankle Arthrodesis Nail, right T2 Ankle 10x300mm, Product Number 18191030SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2406-2018 Class II | Femoral Nail, RIGHT T2 GTN 14x460 mm, Product Number 18511446SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2405-2018 Class II | Femoral Nail, RIGHT T2 GTN 9x320 mm, Product Number 18510932SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2404-2018 Class II | Femoral Nail, LEFT T2 GTN 14x300 mm, Product Number 18501430SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2403-2018 Class II | Femoral Nail, LEFT T2 GTN 12x360 mm, Product Number 18501236SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2402-2018 Class II | Femoral Nail, LEFT T2 GTN 10x360 mm, Product Number 18501036SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2401-2018 Class II | Femoral Nail, A/R, R1500 T2 Femur 12x380 mm, Product Number 18281238SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2400-2018 Class II | Femoral Nail, A/R, R1500 T2 Femur 12x360 mm, Product Number 18281236SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2399-2018 Class II | Femoral Nail, A/R, R1500 T2 Femur 12x300 mm, Product Number 18281230SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2398-2018 Class II | Femoral Nail, A/R, R1500 T2 Femur 10x320 mm, Product Number 18281032SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2397-2018 Class II | Femoral Nail, A/R T2 Femur 15x240 mm, Product Number 18251524SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2396-2018 Class II | Femoral Nail, A/R T2 Femur 12x360 mm, Product Number 18251236SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2395-2018 Class II | Femoral Nail, A/R T2 Femur 10x340 mm, Product Number 18251034SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2394-2018 Class II | Femoral Nail, A/R T2 Femur 10x320 mm, Product Number 18251032SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2393-2018 Class II | Tibial Nail, Standard T2 Tibia 12x315 mm, Product Number 18221231SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-1526-2018 Class II | Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures…The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with… | 03/12/2018Terminated |
| Z-0974-2018 Class II | CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus…The recalled products were shipped without the required temperature control packaging, therefore could… | 01/25/2018Open, Classified |
| Z-2057-2018 Class II | 3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The…Inadvertent shipment of expired units. | 12/21/2017Completed |
| Z-0838-2018 Class II | ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.… | 11/17/2017Terminated |
| Z-0837-2018 Class II | STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model…Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. | 11/17/2017Terminated |
| Z-0836-2018 Class II | STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a.…Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. | 11/17/2017Terminated |
| Z-0835-2018 Class II | StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC…Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. | 11/17/2017Terminated |
| Z-1910-2016 Class II | Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is…Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in… | 05/04/2016Terminated |
| Z-1635-2016 Class II | CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The…Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor… | 04/12/2016Terminated |
| Z-1634-2016 Class II | CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot…Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor… | 04/12/2016Terminated |