Pin, Fixation, Smooth
FDA product code HTY · Class II (moderate risk) · 21 CFR 888.3040 · Orthopedic
205510(k) clearances
0PMA approvals
31recalls
Implantimplanted device
Manufacturers
- Arthrex, Inc. 13
- OSSIO , Ltd. 6
- Synthes (Usa) 5
- Biomet, Inc. 5
- The Huxley Instrument Corp. 4
- Bioretec, Ltd. 4
- OrthoPediatrics Corp. 4
- Bonutti Research, Inc. 3
- J.B.S., S.A. 3
- Howmedica Corp. 3
- Paragon 28, Inc. 3
- Mitek Products 3
- Memometal Technologies 3
- O'Tec Corp. 3
- Inion , Ltd. 3
- Hand Innovations, Inc. 3
- Onyx Medical Corp. 2
- Bionx Implants, Inc. 2
- Buckman Co., Inc. 2
- Opus Medical, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262722 | Primal K-Wire (P99-193-1410)HTY · Special | Paragon 28, Inc. | 08/28/2026SE |
| K253325 | ZipToe Hammertoe Fusion SystemHTY · Traditional | Toetal Solutions | 12/29/2025SE |
| K252657 | Impact PEEK Union Nail SystemHTY · Special | Nvision Biomedical Technologies, Inc. | 09/19/2025SE |
| K250315 | Ronavis FX (FX-001)HTY · Traditional | AIRS, Inc. | 08/01/2025SE |
| K251362 | PediFlex Flexible Nail SystemHTY · Traditional | OrthoPediatrics Corp. | 06/24/2025SE |
| K250646 | Impact PEEK Union Nail SystemHTY · Traditional | Nvision Biomedical Technologies | 06/11/2025SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | Biomet, Inc. | 05/22/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | OSSIO , Ltd. | 12/01/2023SE |
| K231147 | Hammerdesis Interphalangeal Fusion SystemHTY · Traditional | Intelivation | 09/14/2023SE |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | OSSIO , Ltd. | 09/13/2023SE |
| K231905 | Electro-Spec Steri-CapsHTY · Traditional | Electro-Spec, Inc. | 08/14/2023SE |
| K231339 | Tyber Medical Pin and Wire System (various)HTY · Traditional | Tyber Medical, LLC | 07/06/2023SE |
| K221283 | Hammertoe Truss System (HTS)HTY · Traditional | 4Web Medical, Inc. | 09/06/2022SE |
| K220906 | Secure-LockHTY · Traditional | Xiros, Ltd. | 07/22/2022SE |
| K213982 | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide WiresHTY · Traditional | Pacific Instruments | 02/17/2022SE |
| K211789 | restor3d Pin ImplantsHTY · Traditional | Restor3D | 01/04/2022SE |
| K211439 | Small Bone Nailing SystemHTY · Traditional | Skeletal Dynamics, Inc. | 09/30/2021SE |
| K203698 | CoLink Sfx Implant SystemHTY · Traditional | In2bones USA, LLC | 05/04/2021SE |
| K203475 | LimaCorporate Kirschner WireHTY · Traditional | Lima Corporate S.P.A. | 02/05/2021SE |
| K201838 | PediFlex Flexible Nail SystemHTY · Traditional | OrthoPediatrics Corp. | 01/29/2021SE |
| K203465 | OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail…HTY · Traditional | OSSIO , Ltd. | 01/06/2021SE |
| K202777 | VeriFixx Small Bone ImplantHTY · Traditional | Armis Biopharma, Inc. | 11/17/2020SE |
| K201803 | OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation ImplantHTY · Traditional | OSSIO , Ltd. | 10/16/2020SE |
| K201715 | Smart Toe II, X FuseHTY · Traditional | Stryker GmbH | 08/05/2020SE |
| K200068 | Arthrex DynaNite K-WireHTY · Traditional | Arthrex, Inc. | 06/29/2020SE |
| K190652 | OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation ImplantHTY · Traditional | OSSIO , Ltd. | 03/06/2020SE |
| K190926 | Hammertoe Truss System (HTS)HTY · Traditional | 4Web, Inc. | 07/23/2019SE |
| K190287 | Arthrex DynaNite® PIP (Hammertoe) ImplantHTY · Traditional | Arthrex, Inc. | 05/03/2019SE |
| K183228 | HammerToe Compression SystemHTY · Traditional | Paragon 28, Inc. | 01/25/2019SE |
| K181180 | OSSIO Pin Product FamilyHTY · Traditional | OSSIO , Ltd. | 01/10/2019SE |
| K180087 | A.M. Surgical Intramedullary Fixation DeviceHTY · Traditional | A.M. Surgical, Inc. | 05/18/2018SE |
| K171715 | HammerTube SystemHTY · Traditional | Paragon 28 | 03/05/2018SE |
| K172485 | Footmotion HammerToeHTY · Traditional | Newclip Technics | 03/02/2018SE |
| K173616 | DIP Arthrodesis SystemHTY · Traditional | In2bones Sas | 01/19/2018SE |
| K173013 | WishBone K-Wire SystemHTY · Traditional | Wishbone Medical, Inc. | 12/14/2017SE |
| K173051 | Orthofix MJ-FLEX THE NEW METAIZEAU NAILHTY · Traditional | Orthofix Srl | 11/16/2017SE |
| K170326 | dynaMX Intramedullary ImplantHTY · Traditional | Arthrex, Inc. | 07/20/2017SE |
| K170418 | Stryker SonicPin SystemHTY · Traditional | Stryker Trauma GmbH | 06/20/2017SE |
| K163327 | Precifit Medical Kirschner WiresHTY · Traditional | Precifit Medical, Ltd. | 05/08/2017SE |
| K161489 | Syntorr K-wire and Pin SystemHTY · Traditional | Syntorr, Inc. | 09/16/2016SE |
| K160264 | Additive Orthopaedics Hammertoe Correction SystemHTY · Traditional | Additive Orthopaedics, LLC | 06/01/2016SE |
| K160194 | StarFuse Interphalangeal PinHTY · Traditional | Phalanx Innovations | 04/26/2016SE |
| K152662 | S-WireHTY · Traditional | Spinal Resources, Inc. | 03/09/2016SE |
| K153204 | In2Bones Kirschner wireHTY · Traditional | In2bones Sas | 02/01/2016SE |
| K152627 | IFS Fixation Scaffold SystemHTY · Traditional | Metric Medical Devices, Inc. | 01/13/2016SE |
| K151876 | Bio2 Fusion Implant SystemHTY · Traditional | Bio2 Technologies, Inc. | 12/30/2015SE |
| K142478 | opti-ToeHTY · Traditional | Graham Medical Technologies, LLC (D.B.A.Gramedica) | 05/29/2015SE |
| K150626 | Rush Medullary PinsHTY · Traditional | Zimmer, Inc. | 05/01/2015SE |
| K150416 | ProCinch Adjustable Loop DeviceHTY · Traditional | Stryker Endoscopy | 04/17/2015SE |
| K143702 | Arthrex Blunt Tip Screws with Fiber TapeHTY · Traditional | Arthrex, Inc. | 04/09/2015SE |
| K143049 | LYNC intramedullary implantHTY · Traditional | Novastep | 02/19/2015SE |
| K143618 | Kirschner Wires, Steinmann PinsHTY · Traditional | Zimmer, Inc. | 02/06/2015SE |
| K143063 | Stryker SonicPin System, Stryker SonicAnchor SystemHTY · Traditional | Stryker Trauma GmbH | 01/27/2015SE |
| K141714 | Pro-Toe X-Flex Hammertoe Fixation SystemHTY · Traditional | Wrightmedicaltechnologyinc | 10/24/2014SE |
| K142134 | C-Wire Double Ended Orthopedic WiresHTY · Traditional | Conmed Corporation, Largo | 09/12/2014SE |
| K141004 | Intraosseous Fixation SystemHTY · Special | Orthohelix Surgical Designs, Inc. | 08/21/2014SE |
| K141577 | Arthrex Pip DartHTY · Special | Arthrex, Inc. | 07/18/2014SE |
| K133932 | Inion FreedompinHTY · Traditional | Inion OY | 04/11/2014SE |
| K133477 | Toegrip, Implant for Proximal Inter-Phalangeal ArthrodesisHTY · Traditional | Synchro Medical | 02/10/2014SE |
| K133950 | Activapin HT, Fuse Link (Private Labled for Footmind, Inc.)HTY · Special | Bioretec, Ltd. | 01/22/2014SE |
| K133520 | Hammerlock 2HTY · Traditional | Biomedical Enterprises, Inc. | 01/09/2014SE |
| K132895 | WMT Implantable K-WireHTY · Traditional | Wrightmedicaltechnologyinc | 10/23/2013SE |
| K131640 | Smooth or Threaded Metallic Bone FastenerHTY · Traditional | Biomedical Ent., Inc. | 10/16/2013SE |
| K130105 | Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl PEEK Cross Pin SystemHTY · Traditional | Depuy Mitek, A Johnson & Johnson Company | 05/17/2013SE |
| K122415 | X-Fix Dynamic External DistractorHTY · Traditional | Arex USA, LLC | 03/15/2013SE |
| K121008 | Trilliant Surgical K-WiresHTY · Traditional | Trilliant Surgical, Ltd. | 06/04/2012SE |
| K121004 | Apex Kirschner Wires and Steinmann PinsHTY · Special | Apex Tools & Orthopedics Co. | 04/24/2012SE |
| K120165 | Intraosseous Fixation SystemHTY · Traditional | Orthohelix Surgical Designs, Inc. | 04/17/2012SE |
| K103623 | Newdeal Interphalangeal ImplantHTY · Traditional | Newdeal Sas | 03/20/2012SE |
| K112990 | Acl Tightrope,Acl Tightrope Duuble BundleHTY · Traditional | Arthrex, Inc. | 12/19/2011SE |
| K112675 | Arrow-Lok Digital SystemHTY · Traditional | Arrowhead Medical Device Technologies, LLC | 12/12/2011SE |
| K112197 | Memometal Intra-Medullary Bone FastenerHTY · Special | Memometal Technologies | 11/17/2011SE |
| K112254 | Apex Kirschner Wires and Steinmann PinsHTY · Traditional | Apex Tools & Orthopedics Co. | 10/11/2011SE |
| K110123 | PCL TightropeHTY · Traditional | Arthrex, Inc. | 04/28/2011SE |
| K110047 | Verticor K-Wire SystemHTY · Traditional | Verticor, Ltd. | 02/28/2011SE |
| K101837 | Acl Tightrope Double BundleHTY · Traditional | Arthrex, Inc. | 12/28/2010SE |
| K102215 | Kirschner Wires, Steinman PinsHTY · Traditional | Evergreen Orthopedic Research Lab | 11/09/2010SE |
| K102072 | Memometal Implants (K-Snap & Ti-Fuse)HTY · Traditional | Memometal Technologies | 11/03/2010SE |
| K100926 | Arrowhead Fixation DeviceHTY · Traditional | Arrow Products, Inc. | 10/29/2010SE |
| K100736 | Kirschner and Guide WiresHTY · Traditional | Smt Schilling Metalltechnik GmbH | 09/10/2010SE |
| K094043 | LigamentotaxorHTY · Traditional | Arex USA | 08/17/2010SE |
| K100652 | Acl TightropeHTY · Special | Arthrex, Inc. | 06/23/2010SE |
| K091955 | Stryker Sonicpin SystemHTY · Traditional | Howmedica Osteonics Corp. | 04/02/2010SE |
| K091951 | HammerlockHTY · Traditional | Biomedical Ent., Inc. | 02/19/2010SE |
| K092038 | Aptus K-Wire SystemHTY · Traditional | Medartis AG | 09/23/2009SE |
| K083490 | Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685HTY · Traditional | Biopro, Inc. | 03/18/2009SE |
| K082375 | Orthopediatrics Pediflex Flexible Nail SystemHTY · Traditional | OrthoPediatrics Corp. | 10/17/2008SE |
| K082017 | Starr Frame Steinmann PinHTY · Abbreviated | Starr Frame, LLC | 10/10/2008SE |
| K080879 | Activatm Product Group Including Bioabsorbable Devices Activapin Fusion, Activanailtm…HTY · Traditional | Bioretec, Ltd. | 06/24/2008SE |
| K081097 | Orthopediatrics Pediflex Flexible Nail SystemHTY · Traditional | Orthopediatrics, LLC | 06/03/2008SE |
| K073311 | Osteotrans-Ot PinHTY · Traditional | Takiron Co., Ltd. | 05/13/2008SE |
| K073674 | Bone Fixation Wire (Kirschner Wire)HTY · Traditional | Signal Medical Corp. | 03/24/2008SE |
| K071616 | Arc Surgical Biotrak Pin SystemHTY · Traditional | Arc Surgical, LLC | 12/19/2007SE |
| K071863 | Activapin, Nexfix RFS Pin, Nexfix Resorbable Fixation System (RFS)HTY · Special | Bioretec, Ltd. | 08/31/2007SE |
| K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseHTY · Traditional | Memometal Technologies | 07/26/2007SE |
| K070555 | Orthopro Steinman Pins and Kirschner WiresHTY · Traditional | Orthopro, LLC | 07/13/2007SE |
| K070561 | Kmedic Internal/External Fixation DevicesHTY · Abbreviated | Teleflex Medical | 05/25/2007SE |
| K063719 | Arthrex Crosspin, Model AR-1964PHTY · Traditional | Arthrex, Inc. | 03/06/2007SE |
| K061607 | Storm Operating Kit, Model 1-10-0HTY · Traditional | Intelligent Orthopaedics, Ltd. | 07/18/2006SE |
| K061164 | ActivapinHTY · Traditional | Bioretec, Ltd. | 07/06/2006SE |
| K060654 | Dsi Pins and WiresHTY · Traditional | Delta Surgical Instruments, Inc. | 04/28/2006SE |
| K060283 | Transet SystemHTY · Special | Bonutti Research, Inc. | 02/22/2006SE |
| K052736 | Arthrex K-Wire ,Threaded Models AR-8990 to 899X, AR-8991T to AR-899XTHTY · Traditional | Arthrex, Inc. | 11/03/2005SE |
| K051605 | Sbi K-WiresHTY · Traditional | Small Bone Innovations, LLC | 08/10/2005SE |
| K050259 | Arthrex Bio-PinHTY · Traditional | Arthrex, Inc. | 05/27/2005SE |
| K043339 | Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG…HTY · Traditional | Xtremi-T, LLC | 04/18/2005SE |
| K050275 | Modification to: Inion Otps Biodegradable PinHTY · Special | Inion , Ltd. | 03/07/2005SE |
| K043106 | Pinn-Acl CrosspinHTY · Traditional | Linvatec Corp. | 01/19/2005SE |
| K041355 | Humeral StapleHTY · Traditional | Smith & Nephew, Inc. | 07/30/2004SE |
| K041157 | Modification to Small Bone Fixation SystemHTY · Traditional | Hand Innovations, Inc. | 07/30/2004SE |
| K041288 | Modification to SmartpinHTY · Special | Linvatec Biomaterials, Inc. | 06/10/2004SE |
| K040500 | Arthrotek LactonailHTY · Traditional | Arthrotek, Inc. | 05/25/2004SE |
| K033717 | Transet Fracture Fixation SystemHTY · Traditional | Bonutti Research, Inc. | 02/25/2004SE |
| K033968 | Hansson Pin SystemHTY · Traditional | Howmedica Osteonics Corp. | 02/20/2004SE |
| K033406 | Small Bone Fixation SystemHTY · Special | Hand Innovations, Inc. | 01/15/2004SE |
| K024185 | BiodhocHTY · Traditional | Future Medical Systems, SA | 01/15/2004SE |
| K032687 | Ace Nancy NailHTY · Traditional | DePuy Orthopaedics, Inc. | 10/06/2003SE |
| K031712 | Inion Otps Biodegradable PinHTY · Traditional | Inion , Ltd. | 08/28/2003SE |
| K031083 | Opus Magnum Implant System, Model OM-1500HTY · Traditional | Opus Medical, Inc. | 06/12/2003SE |
| K030665 | Bone WireHTY · Traditional | Stork Instrumente GmbH | 03/25/2003SE |
| K022597 | K-FixHTY · Traditional | New Deal, S.A. | 11/01/2002SE |
| K022599 | Newdeal K WireHTY · Traditional | New Deal, S.A. | 10/30/2002SE |
| K022531 | 2MM Pediatric Flex NailHTY · Special | Biomet, Inc. | 08/26/2002SE |
| K013888 | Fixation (Steinmann) PinsHTY · Traditional | Miltex, Inc. | 05/01/2002SE |
| K014305 | Resorbable Lactosorb-L Acl CrosspinHTY · Traditional | Arthrotek, Inc. | 03/29/2002SE |
| K013781 | Rididfix 2.7MM BTB Cross Pin KitHTY · Traditional | Mitek Products | 02/06/2002SE |
| K013424 | Intramedullary Fixation System for the HandHTY · Traditional | Hand Innovations, Inc. | 12/20/2001SE |
| K012125 | Opus Magnum Anchor & InserterHTY · Traditional | Opus Medical, Inc. | 09/17/2001SE |
| K012161 | Flex-NailsHTY · Traditional | Fixano SA | 08/24/2001SE |
| K011522 | Resorbable Bone PinsHTY · Traditional | Biomet, Inc. | 07/31/2001SE |
| K010983 | Plla PinHTY · Special | Bionx Implants, Inc. | 06/13/2001SE |
| K010479 | Multitak Conical Tip Bone Soft Tissue Suture AnchorHTY · Traditional | Bonutti Research, Inc. | 05/08/2001SE |
| K003527 | Modification to Synthes (USA) PolypinHTY · Traditional | Synthes (Usa) | 04/09/2001SE |
| K003659 | Plga Pin, Model 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260HTY · Traditional | Bionx Implants, Inc. | 02/20/2001SE |
| K002125 | Pins and WiresHTY · Traditional | Implant Resource, Inc. | 10/11/2000SE |
| K991971 | Arthrex Chondral Dart, Model AR-4005B-18HTY · Traditional | Arthrex, Inc. | 08/04/2000SE |
| K994232 | Phalangeal Fixation SystemHTY · Traditional | Medcanica, Inc. | 03/01/2000SE |
| K991064 | Metacarpal Fixation SystemHTY · Traditional | Medcanica, Inc. | 06/23/1999SE |
| K990291 | Lactosorb Bone PinHTY · Traditional | Biomet, Inc. | 03/23/1999SE |
| K983121 | Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216…HTY · Traditional | Syntec Scientific Corp. | 10/05/1998SE |
| K982719 | The Bone TieHTY · Traditional | Surgicraft , Ltd. | 09/25/1998SE |
| K980854 | Retrograde Pediatric NailHTY · Traditional | Encore Orthopedics, Inc. | 08/11/1998SE |
| K974341 | Mitek BTB Absorbable (Pla) Cross PinHTY · Traditional | Mitek Products | 04/16/1998SE |
| K974291 | Mitek BTB Absorbable (Pla) Cross PinHTY · Traditional | Mitek Products | 03/05/1998SE |
| K973240 | Synthes Proximal Femoral Nail(Pfn) System ModificationHTY · Traditional | Synthes (Usa) | 11/20/1997SE |
| K971962 | Osteo Kirschner WiresHTY · Traditional | Osteonics Corp. | 08/11/1997SE |
| K971783 | Synthes Elastic Intramedullary Nail (Ein) SystemHTY · Traditional | Synthes (Usa) | 07/18/1997SE |
| K971453 | Orthotec K-Cap SystemHTY · Traditional | Orthotech | 06/24/1997SE |
| K961608 | Synthes (U.S.A.) PolypinHTY · Traditional | Synthes (Usa) | 05/09/1997SE |
| K970733 | Synthes Titanium Diastal Femoral Nail (Ti DFN) SystemHTY · Traditional | Synthes (Usa) | 04/02/1997SE |
| K970036 | Fixation Pin or RodHTY · Traditional | United States Surgical, A Division of Tyco Healthc | 03/25/1997SE |
| K970013 | Biorigid Nail TibiaHTY · Traditional | Aap GmbH and Co. Betriebs KG | 03/13/1997SE |
| K964500 | Acumed Tension Band PinHTY · Traditional | Acu Med, Inc. | 12/09/1996SE |
| K964087 | Block Stop WiresHTY · Traditional | Ferguson Medical | 11/25/1996SE |
| K963367 | RMS K-WireHTY · Traditional | Rms Div. | 10/30/1996SE |
| K961522 | Kirschner Wire (K-Wire) and Steinmann PinHTY · Traditional | Synvasive Technology, Inc. | 09/23/1996SE |
| K960642 | Nancy NailHTY · Traditional | Landos, Inc. | 05/17/1996SE |
| K960483 | Steinman PinHTY · Traditional | American Medical Specialties, Inc. | 04/09/1996SE |
| K960482 | K-WireHTY · Traditional | American Medical Specialties, Inc. | 04/09/1996SE |
| K960385 | Sterile Kirschner Wires and Steinmann PinsHTY · Traditional | Depuy, Inc. | 03/27/1996SE |
| K955806 | Howmedica Bioabsorbable PinHTY · Traditional | Howmedica, Inc. | 02/15/1996SE |
| K954543 | Go Universalk-Wire Fluted DrillHTY · Traditional | Genesis Orthopedics, Inc. | 12/08/1995SN |
| K953194 | Lactosorb Bone PinHTY · Traditional | Biomet, Inc. | 10/31/1995SN |
| K954001 | Spetzler PinHTY · Traditional | Howmedica Corp. | 10/26/1995SE |
| K943856 | Fixation Pins/WiresHTY · Traditional | Acu Med, Inc. | 07/06/1995SE |
| K945639 | Spetzler PinHTY · Traditional | Howmedica Corp. | 04/14/1995SN |
| K940673 | J.B.S. Self-Tapping Threaded PinHTY · Traditional | J.B.S., S.A. | 11/14/1994SE |
| K940669 | J.B.S. B.A.C. PinHTY · Traditional | J.B.S., S.A. | 11/14/1994SE |
| K940666 | JBS Smooth Fixation PinHTY · Traditional | J.B.S., S.A. | 11/14/1994SE |
| K941434 | K-Wires and Steinmann PinsHTY · Traditional | Omega Surgical Instruments, Inc. | 10/03/1994SE |
| K925098 | Biofix Absorbable Self-Reinforced Poly-L-LactideHTY · Traditional | Bioscience, Inc. | 07/19/1994SN |
| K931836 | Acufex Smooth and Threaded PinsHTY · Traditional | Acufex Microsurgical, Inc. | 06/28/1994SE |
| K931697 | Fixation PinHTY · Traditional | Orthologic Corp. | 05/12/1994SE |
| K930969 | Baumer PinsHTY · Traditional | Baumer Ortopedia , Ltd. | 03/29/1994SE |
| K932348 | Orthopedic Smooth Pin FixationHTY · Traditional | Osteomed Corp. | 03/01/1994SE |
| K940109 | Tava K-WireHTY · Traditional | Tava Surgical Instruments | 02/22/1994SE |
| K922766 | Acufex Biofix Absorbable Fixation Rod-ModificationHTY · Traditional | Acufex Microsurgical, Inc. | 07/09/1993SESK |
| K925301 | Oti Orthopedic Fastener SystemHTY · Traditional | Osteo Technology, Inc. | 03/16/1993SE |
| K922194 | Osteo Steinmann PinHTY · Traditional | Osteo AG | 07/23/1992SE |
| K922193 | Osteo Kirschner WireHTY · Traditional | Osteo AG | 07/23/1992SE |
| K911375 | G-PinHTY · Traditional | Dr.M.A.Galluzzo | 09/23/1991SE |
| K911505 | Fixation WireHTY · Traditional | Simpex, Inc. | 04/12/1991SE |
| K911452 | Fixation PinHTY · Traditional | Simpex, Inc. | 04/12/1991SE |
| K905345 | K-WireHTY · Traditional | O'Tec Corp. | 12/11/1990SE |
| K905341 | Rush PinHTY · Traditional | O'Tec Corp. | 12/11/1990SE |
| K905337 | Steinman PinHTY · Traditional | O'Tec Corp. | 12/11/1990SE |
| K903265 | Steinman PinHTY · Traditional | Onyx Medical Corp. | 07/30/1990SE |
| K903264 | K-WireHTY · Traditional | Onyx Medical Corp. | 07/30/1990SE |
| K901273 | L.M.S. Self-Detachable Broach with StopHTY · Traditional | Med-Tek Corp. | 06/05/1990SE |
| K890902 | Biofix* Biodegradable Fixation RodHTY · Traditional | Davis & Geck, Inc. | 11/03/1989SE |
| K895079 | Ace Beaded K-Wires Ace Olive WiresHTY · Traditional | Buckman Co., Inc. | 09/13/1989SE |
| K874913 | Orthomet Pin SystemHTY · Traditional | Orthomet, Inc. | 01/07/1988SE |
| K872842 | Pin, Hip, KnowlesHTY · Traditional | Military Engineering, Inc. | 08/07/1987SE |
| K864912 | PDS (Polydioxanon) Absorbable PinHTY · Traditional | Johnson & Johnson Professionals, Inc. | 07/09/1987SE |
| K863734 | Steinmann(Threaded/Calibrated),Knowles&Hogie PinsHTY · Traditional | Micro-Aire Surgical Instruments, Inc. | 10/20/1986SE |
| K863119 | Cannulated Lag ScrewsHTY · Traditional | Downs Surgical , Ltd. | 09/03/1986SE |
| K860590 | Ace Unilateral FixatorHTY · Traditional | Buckman Co., Inc. | 03/07/1986SE |
| K852563 | Pin Set, Bone Rush, 7-1/4 Thru 18-1/2 Inches LongHTY · Traditional | The Huxley Instrument Corp. | 06/28/1985SE |
| K852562 | Pin Set, Bone, Rush, 4 Thru 10 1/2 Inches LongHTY · Traditional | The Huxley Instrument Corp. | 06/28/1985SE |
| K852561 | Pin Set, Bonem, Rush, 1 Thru 10 Inches LongHTY · Traditional | The Huxley Instrument Corp. | 06/28/1985SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2958-2026 Class II | Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530…Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following… | Arrowhead DE LLC | 06/23/2026Open, Classified |
| Z-3172-2024 Class II | DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastenerSmith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a… | Smith & Nephew, Inc. | 07/09/2024Open, Classified |
| Z-3171-2024 Class II | DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastenerSmith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a… | Smith & Nephew, Inc. | 07/09/2024Open, Classified |
| Z-1468-2022 Class II | HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)Due to Titanium plasma coating not present implant. | Paragon 28, Inc. | 05/26/2022Open, 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… | Stryker GmbH | 03/28/2022Open, Classified |
| Z-0707-2022 Class II | Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35SOne lot of product was distributed in unsealed packaging | Brasseler USA, Medical L.L.C. | 01/28/2022Terminated |
| Z-0884-2020 Class II | Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length…103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth… | Brasseler USA I Lp | 12/11/2019Terminated |
| Z-1635-2020 Class II | 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only…The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect… | Trilliant Surgical, LLC | 11/04/2019Terminated |
| Z-2242-2018 Class II | 3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin for insertion…The firm is recalling various trauma guide wires due to insufficient packaging design verification and… | Zimmer Biomet, Inc. | 05/16/2018Terminated |
| Z-2241-2018 Class II | RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of…The firm is recalling various trauma guide wires due to insufficient packaging design verification and… | Zimmer Biomet, Inc. | 05/16/2018Terminated |
| Z-2240-2018 Class II | 3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin for insertion…The firm is recalling various trauma guide wires due to insufficient packaging design verification and… | Zimmer Biomet, Inc. | 05/16/2018Terminated |
| Z-2239-2018 Class II | BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of…The firm is recalling various trauma guide wires due to insufficient packaging design verification and… | Zimmer Biomet, Inc. | 05/16/2018Terminated |
| Z-2238-2018 Class II | G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 Intended to be…The firm is recalling various trauma guide wires due to insufficient packaging design verification and… | Zimmer Biomet, Inc. | 05/16/2018Terminated |
| Z-2237-2018 Class II | G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of…The firm is recalling various trauma guide wires due to insufficient packaging design verification and… | Zimmer Biomet, Inc. | 05/16/2018Terminated |
| Z-2236-2018 Class II | G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for insertion of…The firm is recalling various trauma guide wires due to insufficient packaging design verification and… | Zimmer Biomet, Inc. | 05/16/2018Terminated |
| Z-2235-2018 Class II | BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin for insertion…The firm is recalling various trauma guide wires due to insufficient packaging design verification and… | Zimmer Biomet, Inc. | 05/16/2018Terminated |
| Z-2234-2018 Class II | GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for…The firm is recalling various trauma guide wires due to insufficient packaging design verification and… | Zimmer Biomet, Inc. | 05/16/2018Terminated |
| Z-2233-2018 Class II | BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion…The firm is recalling various trauma guide wires due to insufficient packaging design verification and… | Zimmer Biomet, Inc. | 05/16/2018Terminated |
| Z-2232-2018 Class II | BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion…The firm is recalling various trauma guide wires due to insufficient packaging design verification and… | Zimmer Biomet, Inc. | 05/16/2018Terminated |
| Z-2231-2018 Class II | DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin for insertion…The firm is recalling various trauma guide wires due to insufficient packaging design verification and… | Zimmer Biomet, Inc. | 05/16/2018Terminated |
| Z-2230-2018 Class II | DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion…The firm is recalling various trauma guide wires due to insufficient packaging design verification and… | Zimmer Biomet, Inc. | 05/16/2018Terminated |
| Z-1407-2017 Class II | MicroAire K-WiresMislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single… | MicroAire Surgical Instruments, LLC | 02/21/2017Terminated |
| Z-0881-2017 Class II | K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part…The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is… | Amendia, Inc | 11/22/2016Terminated |
| Z-0087-2017 Class II | Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A…The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and one (1)… | Zimmer Biomet, Inc. | 08/02/2016Terminated |
| Z-1822-2016 Class II | Various trauma and sports medicine instruments and implants. Pin, fixation, smooth.Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | Biomet, Inc. | 04/01/2016Terminated |
| Z-1515-2014 Class II | The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates.…Manufacturing of these devices with a grade of stainless steel that is not within specifications. | Acumed LLC | 03/26/2014Terminated |
| Z-2159-2013 Class II | Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile…A medical device used in surgical procedures was packaged in a pouch in which a defective seal may… | MicroAire Surgical Instruments, LLC | 08/12/2013Terminated |
| Z-2158-2013 Class II | Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier…A medical device used in surgical procedures was packaged in a pouch in which a defective seal may… | MicroAire Surgical Instruments, LLC | 08/12/2013Terminated |
| Z-2243-2013 Class II | Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S…Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed. | Synthes USA HQ, Inc. | 04/18/2013Terminated |
| Z-2199-2010 | PERI-LOC, 2.0 MM X 228 MM, K-WIRE W/TROCAR POINT, CO-CR, REF 71173361, QTY: (6), STERILE…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | Smith & Nephew Inc | 06/28/2010Terminated |
| Z-1481-2009 | Zimmer Steinmann Pins, 7/64 in. (2.8 mm) diameter, 9 in. (229mm) length, style 6…The package contains pins with an incorrect diameter. | Zimmer Inc. | 05/01/2009Terminated |