Stryker Spine
Medical device manufacturer in Allendale, NJ.
75510(k) clearances
1PMA approvals
99recalls
Device types
- NKB Thoracolumbosacral Pedicle Screw System 22
- MQP Spinal Vertebral Body Replacement Device 8
- KWP Appliance, Fixation, Spinal Interlaminal 7
- MNI Orthosis, Spinal Pedicle Fixation 7
- KWQ Appliance, Fixation, Spinal Intervertebral… 6
- ODP Intervertebral Fusion Device With Bone… 6
- MAX Intervertebral Fusion Device With Bone… 5
- MNH Orthosis, Spondylolisthesis Spinal Fixation 4
- MQV Filler, Bone Void, Calcium Compound 2
- NQW Orthosis, Spine, Plate, Laminoplasty, Metal 1
- GXZ Electrode, Needle 1
- OVD Intervertebral Fusion Device With… 1
- FST Light, Surgical, Fiberoptic 1
- PEK Spinous Process Plate 1
- PLR Spinal Vertebral Body Replacement Device -… 1
- OLO Orthopedic Stereotaxic Instrument 1
- OVE Intervertebral Fusion Device With… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | 07/17/2026SE |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…MQV · Special | 04/24/2026SE |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…KWQ · Traditional | 11/07/2024SE |
| K242280 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…MQV · Special | 08/29/2024SE |
| K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…NKB · Traditional | 06/08/2023SE |
| K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…ODP · Traditional | 02/14/2023SE |
| K203205 | Navigated Spine InstrumentsOLO · Traditional | 03/23/2021SE |
| K200666 | Stryker Xia 3 Power AdaptorNKB · Special | 04/23/2020SE |
| K183249 | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…MAX · Traditional | 07/25/2019SE |
| K183071 | VLIFT-s Vertebral Body Replacement SystemPLR · Special | 01/10/2019SE |
| K181014 | Tritanium PL CageMAX · Traditional | 07/18/2018SE |
| K171496 | Tritanium C Anterior Cervical CageODP · Traditional | 09/06/2017SE |
| K161407 | Ascential IBD PEEKc SpacerODP · Special | 07/15/2016SE |
| K152532 | AERO -C Cervical Cage SystemODP · Traditional | 12/18/2015SE |
| K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…NKB · Special | 12/17/2013SE |
| K132968 | Univise Spinous Process Fixation Plate (35MM, 40MM)PEK · Traditional | 11/18/2013SE |
| K122845 | ES2 Spinal System Model 48280XXXXNKB · Traditional | 12/07/2012SE |
| K122637 | Lite Decompression System- Light Cable Model 48089999FST · Traditional | 11/01/2012SE |
| K120869 | Anchor-L Lumbar CageOVD · Traditional | 10/25/2012SE |
| K113666 | Xia 3 Spinal SystemNKB · Traditional | 08/28/2012SESU |
| K120486 | Avs AS PEEK SpacerODP · Traditional | 08/20/2012SE |
| K113802 | Escalate Laminoplasty SystemNQW · Traditional | 04/16/2012SE |
| K111719 | Oasys Spinal SystemKWP · Special | 01/19/2012SE |
| K110419 | Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsGXZ · Traditional | 07/28/2011SE |
| K102606 | Avs Anchor-C Cervical Cage SystemOVE · Traditional | 04/22/2011SE |
| K101183 | Modification to: Oasys SystemKWP · Special | 11/09/2010SE |
| K102235 | Mantis Spinal System & Mantis Redux Spinal SystemNKB · Special | 08/24/2010SE |
| K101051 | Avs A-Lat PEEK Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXMAX · Traditional | 08/12/2010SE |
| K100865 | Ava Navigator PEEK Spacers, Model 48392XXX, 48393XXXMAX · Traditional | 08/11/2010SE |
| K101144 | Modification To:Radius Spinal SystemNKB · Special | 07/08/2010SE |
| K100737 | Modification to: Trio+Spinal Fixation SystemNKB · Special | 04/12/2010SE |
| K093670 | Modification to: Oasys SystemMNH · Special | 03/18/2010SE |
| K092605 | Xia 4.5 Spinal SystemNKB · Special | 12/03/2009SE |
| K092631 | Mantis Redux Spinal SystemNKB · Special | 09/25/2009SE |
| K091946 | Vlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX, 488816XX, 488818XXMQP · Traditional | 09/25/2009SE |
| K091291 | Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodNKB · Special | 06/24/2009SE |
| K083393 | Xia 3 Spinal SystemNKB · Traditional | 04/01/2009SE |
| K082608 | Radius Spinal System, Vitallium Rod #486613601NKB · Special | 10/07/2008SE |
| K080773 | Thor Anterior Plating SystemKWQ · Traditional | 06/09/2008SE |
| K080928 | Xia Spinal System, Stainless Steel Uni-Planar ScrewsNKB · Special | 04/30/2008SE |
| K073470 | Avs PL PEEK Spacers, Models 48351XXX and 48353XXXMAX · Traditional | 03/06/2008SE |
| K080143 | Modification to Stryker Spine Oasys SystemMNI · Special | 02/14/2008SE |
| K073437 | Thor Anterior Plating SystemKWQ · Traditional | 02/13/2008SE |
| K072568 | Modification to Oasys SystemKWP · Special | 10/05/2007SE |
| K071373 | Stryker Spine Xia III Spinal SystemNKB · Traditional | 08/27/2007SE |
| K070631 | Device Modification to Radius Spinal SystemNKB · Special | 07/13/2007SE |
| K063430 | Zero Profile Anterior Cervical Plate (Acp) SystemKWQ · Special | 03/22/2007SE |
| K063428 | Xia Stainless Steel Spinal SystemNKB · Special | 12/11/2006SE |
| K062270 | Radius Spinal SystemNKB · Traditional | 11/22/2006SE |
| K062853 | Modification to Stryker Spine Oasys SystemMNI · Special | 10/24/2006SE |
| K062698 | Trio + Spinal SystemMNI · Special | 10/11/2006SE |
| K061813 | Mantis Spinal SystemMNH · Traditional | 09/19/2006SE |
| K062310 | Reflex Hybrid Acp SystemKWQ · Special | 08/18/2006SE |
| K062132 | Avs PL PEEK Spacer SystemMQP · Special | 08/16/2006SE |
| K061836 | Avs Asl PEEK Spacer SystemMQP · Special | 08/03/2006SE |
| K061854 | Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemNKB · Special | 07/27/2006SE |
| K060506 | Stryker Spine Vlift Vertebral Body Replacement SystemMQP · Traditional | 05/25/2006SE |
| K060979 | Xia Titanium and 4.5 Spinal SystemsNKB · Special | 05/19/2006SE |
| K060748 | Modification to Xia 4.5 Spinal SystemNKB · Special | 04/13/2006SE |
| K060361 | Xia Spinal System, Xia 4.5 Spinal SystemNKB · Traditional | 03/06/2006SE |
| K053115 | Xia Spinal SystemMNI · Special | 12/06/2005SE |
| K052971 | Stryker Spine Trio Spinal Fixation SystemMNI · Special | 11/16/2005SE |
| K051205 | Stryker Spine Avs Asl PEEK SpacerMQP · Traditional | 11/04/2005SE |
| K052761 | Modification to: Xia 4.5 Spinal SystemMNI · Special | 10/11/2005SE |
| K052317 | Modification to: Stryker Spine Oasys SystemMNI · Special | 09/21/2005SE |
| K052181 | Modification to Xia Spinal SystemKWP · Special | 09/08/2005SE |
| K051973 | Modification to: Xia Stainless Steel SystemKWP · Special | 08/18/2005SE |
| K050461 | Xia 4.5 Spinal SystemMNH · Traditional | 07/27/2005SE |
| K050624 | Stryker Spine Avs PL PEEK SpacerMQP · Traditional | 04/11/2005SE |
| K043180 | Stryker Spine Trio PSMNH · Traditional | 03/02/2005SE |
| K050189 | Techtonix SystemKWP · Special | 02/16/2005SE |
| K042571 | Stryker Spine Avs TL PEEK SpacerMQP · Traditional | 02/11/2005SE |
| K043473 | Modification to Xia Spinal SystemKWP · Special | 01/12/2005SE |
| K040731 | Stryker Spine Vertebral SpacerMQP · Traditional | 08/05/2004SE |
| K040261 | Reflex Hybrid Anterior Cervical Plate SystemKWQ · Special | 04/16/2004SE |
PMA approvals
- P950019 Ray Threaded Fusion Cage (Tfc)(Tm) with Instrumentation · 10/29/1996 · 16 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1491-2025 Class II | Monterey AL Implant Inserter; 22mm; Catalog 48019140.Potential for the gold unlock button to separate from the inserter. | 02/28/2025Open, Classified |
| Z-1490-2025 Class II | Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.Potential for the gold unlock button to separate from the inserter. | 02/28/2025Open, Classified |
| Z-1489-2025 Class II | Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.Potential for the gold unlock button to separate from the inserter. | 02/28/2025Open, Classified |
| Z-1488-2025 Class II | Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.Potential for the gold unlock button to separate from the inserter. | 02/28/2025Open, Classified |
| Z-3210-2024 Class II | AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision…Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications… | 08/23/2024Open, Classified |
| Z-0610-2024 Class II | LITe Decompression Snake Arm, REF 48080230Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm… | 11/01/2023Open, Classified |
| Z-2101-2021 Class II | Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN…The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the… | 05/18/2021Terminated |
| Z-2100-2021 Class II | Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN…The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the… | 05/18/2021Terminated |
| Z-1437-2021 Class II | Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar.…Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found… | 03/11/2021Terminated |
| Z-0092-2019 Class II | AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS ARIA 1M PEEK…The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage. | 08/13/2018Terminated |
| Z-0828-2016 Class II | Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by…Reported jamming of the impaction handle when assembled to the Inserter guide at the threads. | 12/18/2015Terminated |
| Z-0852-2016 Class II | AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system…There were two potential interference conditions identified with the way the tubing set attaches to the… | 12/16/2015Terminated |
| Z-0270-2016 Class II | Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide…Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because it does… | 09/25/2015Terminated |
| Z-0222-2016 Class II | Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine…The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of… | 09/08/2015Terminated |
| Z-0803-2015 Class II | Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP…Stryker has received a complaint from customers relating to a fracture during the use of the Specialty… | 10/06/2014Terminated |
| Z-2627-2014 Class II | Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria…Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of… | 07/07/2014Terminated |
| Z-2626-2014 Class II | Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product…Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of… | 07/07/2014Terminated |
| Z-1086-2014 Class II | Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of…Stryker has received complaints from customers relating to fracture along the weld that binds the handle to… | 12/18/2013Terminated |
| Z-0375-2014 Class II | Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench…Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening. | 09/24/2013Terminated |
| Z-1976-2013 Class I | Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini.…Stryker has received reports from customers indicating post-operative fracture of the pin that connects the… | 05/30/2013Terminated |
| Z-0893-2013 Class II | Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA…Surgeons have experienced unthreading of the screwdrivers outer shafts during use. | 12/27/2012Terminated |
| Z-0382-2013 Class II | SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT…Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening. | 08/09/2012Terminated |
| Z-0381-2013 Class II | Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I…Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening. | 08/09/2012Terminated |
| Z-0380-2013 Class II | Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I…Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening. | 08/09/2012Terminated |
| Z-0163-2013 Class II | Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1…Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable which… | 07/05/2012Terminated |
| Z-2235-2012 Class II | The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST…The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo… | 04/25/2012Terminated |
| Z-2155-2012 Class II | LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I…Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base… | 04/23/2012Terminated |
| Z-2033-2012 Class II | Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1…Beginning in February 2011, Stryker Spine began receiving reports related to the shaft of the AVS Navigator… | 01/13/2012Terminated |
| Z-1706-2012 | Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026.…Stryker received four reports regarding a handle which separates at the point where it is welded to the… | 01/12/2012Terminated |
| Z-0175-2012 | Stryker Mantis Rod Inserter Assembly Manufactured by: Stryker Spine SAS Z. I. Marticot -…There have been reports of difficulty in rod rotation using the newly designed Mantis Rod Inserter. | 06/24/2011Terminated |
| Z-2176-2012 Class II | Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a…Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the… | 03/21/2011Terminated |
| Z-1247-2011 | Mantis Tap Sleeve,Mfg by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401-1677.…Stryker Spine has received reports that after sterilization but prior to surgery, cracks were noticed at the… | 01/07/2011Terminated |
| Z-0895-2011 | Disc Space Distractor Label states - Specialty Disc Space Distractor, Mfg by: Stryker…Stryker Spine has received reports of the Disc Space Distractors failing during surgical procedures. | 12/07/2010Terminated |
| Z-1968-2010 | Stryker 18 MM AVS TL Trial Spacer; Catalog number: 48389418. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1967-2010 | Stryker 17 MM AVS TL Trial Spacer; Catalog number: 48389417 Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1966-2010 | Stryker 16 MM AVS TL Trial Spacer; Catalog number: 48389416. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1965-2010 | Stryker 15 MM AVS TL Trial Spacer; Catalog number: 48389415. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1964-2010 | Stryker 14 MM AVS TL Trial Spacer; Catalog number: 48389414. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1963-2010 | Stryker 13 MM AVS TL Trial Spacer; Catalog number: 48389413. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1962-2010 | Stryker 12 MM AVS TL Trial Spacer; Catalog number: 48389412. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1961-2010 | Stryker 11 MM AVS TL Trial Spacer; Catalog number: 48389411. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1960-2010 | Stryker 10 MM AVS TL Trial Spacer; Catalog number: 48389410. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1959-2010 | Stryker 9 MM AVS TL Trial Spacer; Catalog number: 48389409. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1958-2010 | Stryker 8 MM AVS TL Trial Spacer; Catalog number: 48389408. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1957-2010 | Stryker 7 MM AVS TL Trial Spacer; Catalog number: 48389407. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-0792-2010 | Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile; Manufactured for:…Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which… | 01/18/2010Terminated |
| Z-0791-2010 | Stryker Xia Precision System; Jam Shidi 11 Gauge 5 inch; Sterile; Manufactured for:…Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which… | 01/18/2010Terminated |
| Z-0790-2010 | Stryker Xia Precision System; Jam Shidi 10 Gauge 5 inch; Sterile; Manufactured for:…Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which… | 01/18/2010Terminated |
| Z-0789-2010 | Stryker Xia Precision System; Jam Shidi 10 Gauge 9 inch; Sterile; Manufactured for:…Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which… | 01/18/2010Terminated |
| Z-0823-2010 | Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565. Not Sterile…The Xia 3 8.5mm Polyaxial screws, lot A91109 were anodized turquoise instead of Fuchsia. The turquoise color… | 12/30/2009Terminated |
| Z-0763-2010 | Stryker Reflex Hybrid Screw Extractor Inner Shaft; Not Sterile; Manufactured by: Stryker…The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw… | 10/12/2009Terminated |
| Z-0762-2010 | Stryker Reflex Hybrid Screw Extractor; Not Sterile: Manufactured by: Stryker Spine SAS…The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw… | 10/12/2009Terminated |
| Z-0454-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 67MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0453-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 64MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0452-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 61MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0451-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 58MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0450-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 55MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0449-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 52MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0448-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 49MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0447-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 46MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0446-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 43MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0445-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 40MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0444-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 37MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0443-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 34MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0442-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 31MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0441-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 28MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0440-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 25MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0439-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 22MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0438-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 67MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0437-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 64MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0436-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 61MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0435-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 58MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0434-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 55MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0433-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 52MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0432-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 49MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0431-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 46MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0430-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 43MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0429-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 40MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0428-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 37MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0427-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 34MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0426-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 31MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0425-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 28MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0424-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 25MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0423-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 22MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-1886-2009 | Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM Not Sterile: Manufactured by:…The Trio 3.5MM Hex socket has been reported to break under high stresses. | 07/01/2009Terminated |
| Z-1612-2009 | Stryker Mantis Rod Inserter Inner Shaft; Non Sterile; Manufactured by Stryker Spine SAS…The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when… | 04/30/2009Terminated |
| Z-1611-2009 | Stryker Mantis Rod Inserter; Non Sterile, Manufactured by Stryker Spine SAS, Cestas…The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when… | 04/30/2009Terminated |
| Z-0217-2009 | Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile). Manufactured…The Reflex Hybrid 4.0 x 14 mm Variable, Self Tapping Bone Screw, Lot NSZ, was determined to have been… | 08/18/2008Terminated |
| Z-0151-2009 | Ray TFC Device with End Caps: Single Patient use; Sterile; Stryker Spine Ray Cage 7-2021…The label on one side on the Ray TFC Device (Ray Cage) is incorrect. It reads 20 mm x 26 mm instead of 20 mm… | 08/18/2008Terminated |
| Z-2238-2008 | Reflex Revision Screwdriver Inner Shaft is a orthopedic manual surgical instrument that…The Inner Shaft does not extend far enough from the tip of the Revision Screwdriver to fully engage the bone… | 06/05/2008Terminated |
| Z-1378-2008 | Radius Capspin is a non-sterile instrument for use with other devices in spinal surgery.The Radius Capsin has separation of the tip from the inserter. | 02/19/2008Terminated |
| Z-1377-2008 | Radius Rod Persuader is a non-sterile instrument for use with other devices in spinal…The t-bar of the Radius Rod Persuader devices froze due to a loosening screw causing the device to fail. | 02/19/2008Terminated |
| Z-1239-2007 | Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine…Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod | 07/10/2007Terminated |
| Z-1525-2009 | Stryker Xia Dual Anterior Staple; Non Sterile; Catalog number 03820115; Manufactured by…Labeling Issue: The large Xia Anterior Staple was laser marked with an "S", indicating small. | 04/12/2007Terminated |
| Z-0936-2009 | Stryker AVS AL Spacer Trial Inserter; Non Sterile. Catalog number: 48329800 Manufactured…DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and… | 09/08/2006Terminated |
| Z-0986-2009 | Stryker Trio Small Offset Connector Non Sterile; Manufactured by Stryker Spine SAS, Z.I.…Reports were received of the ball ring ejecting from the connector's body when other connectors have already… | 09/05/2006Terminated |
| Z-1960-2009 | Stryker Reflex Hybrid Variable Self-Tapping Screw. Non Sterile. Manufactured by Stryker…Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All… | 06/14/2006Terminated |
| Z-1959-2009 | Stryker Reflex Hybrid variable self-drilling screw. Non Sterile. Manufactured by Stryker…Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All… | 06/14/2006Terminated |
| Z-1958-2009 | Stryker Reflex Hybrid Level Anterior Cervical Plate; Non Sterile; Manufactured by…Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All… | 06/14/2006Terminated |