Synthes, Inc.
Medical device manufacturer in Zuchwil, CH.
26510(k) clearances
0PMA approvals
44recalls
Device types
- HRS Plate, Fixation, Bone 9
- JEY Plate, Bone 4
- GXQ Dura Substitute 2
- KWQ Appliance, Fixation, Spinal Intervertebral… 1
- MQP Spinal Vertebral Body Replacement Device 1
- MNI Orthosis, Spinal Pedicle Fixation 1
- MQV Filler, Bone Void, Calcium Compound 1
- KKY Material, Polytetrafluoroethylene Vitreous… 1
- NDN Cement, Bone, Vertebroplasty 1
- MQN External Mandibular Fixator And/Or Distractor 1
- KTT Appliance, Fixation, Nail/Blade/Plate… 1
- GWO Plate, Cranioplasty, Preformed, Alterable 1
- KCT Sterilization Wrap Containers, Trays… 1
- GXN Plate, Cranioplasty, Preformed, Non-Alterable 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K254093 | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating SystemHRS · Traditional | 03/10/2026SE |
| K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating SystemHRS · Traditional | 03/09/2026SE |
| K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating SystemHRS · Traditional | 03/02/2026SE |
| K243715 | Synthes Patient Specific ImplantsGXN · Traditional | 11/12/2025SE |
| K241927 | Synthes Graphic Case & Tray SystemKCT · Traditional | 03/28/2025SE |
| K233994 | VOLT Proximal Humerus 3.5 Plating SystemHRS · Traditional | 07/26/2024SE |
| K233967 | DePuy Synthes MatrixSTERNUM Fixation SystemHRS · Traditional | 05/09/2024SE |
| K131792 | Synthecel Dura Repair, Synthecel Dura OnlayGXQ · Traditional | 12/16/2013SE |
| K123723 | Synthes Matrixneuro Cranial Plating SystemGWO · Traditional | 09/05/2013SE |
| K122455 | Synthes Small External Fixation System, Synthes Large External Fixation SystemKTT · Traditional | 04/11/2013SE |
| K122647 | Synthes Patient Specific PlateJEY · Traditional | 02/28/2013SE |
| K113567 | Synthes Matrixmadible Plate and Screw SystemJEY · Traditional | 11/19/2012SE |
| K121502 | Synthes Curvilinear Distraction SystemMQN · Traditional | 08/23/2012SE |
| K121574 | Synthes Matrixmadible Plate and Screw SystemJEY · Special | 06/29/2012SE |
| K113071 | Synthecel Dura Replacement DevicesGXQ · Traditional | 01/09/2012SE |
| K113251 | Synthes Matrixmandible Performed Reconstruction PlatesJEY · Special | 12/21/2011SE |
| K110604 | VBB SystemNDN · Traditional | 12/13/2011SE |
| K111323 | Synthes Synpor HD Porous Polyethylene Threr Dimensional ImplantsKKY · Traditional | 11/16/2011SE |
| K112689 | Synthes Sternal Fixation SystemHRS · Special | 10/26/2011SE |
| K093772 | Synthes Sternal Fixation SystemHRS · Traditional | 03/29/2010SE |
| K013072 | Chronos Tricalcium Prosphate (Chronos TCP)MQV · Traditional | 11/26/2002SE |
| K020602 | Synthes Pilon PlateHRS · Traditional | 05/20/2002SE |
| K010108 | Uss-Line ExtensionMNI · Traditional | 06/06/2001SE |
| K003836 | Synthes Synex Spacer SystemMQP · Traditional | 05/29/2001SE |
| K003061 | Synthes Uss (10.0MM Side Opening Screws)KWQ · Special | 10/30/2000SE |
| K982732 | Synthes (USA) Distal Radius Plate System (DRPS)HRS · Traditional | 10/08/1998SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2698-2020 Class II | MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of…One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The… | 06/18/2020Terminated |
| Z-0883-2020 Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product…There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube… | 12/16/2019Terminated |
| Z-0882-2020 Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product…There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube… | 12/16/2019Terminated |
| Z-0881-2020 Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product…There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube… | 12/16/2019Terminated |
| Z-0880-2020 Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product…There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube… | 12/16/2019Terminated |
| Z-0879-2020 Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product…There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube… | 12/16/2019Terminated |
| Z-1514-2018 Class II | Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and…There is a potential for the connection screw of the stem extractor to break. | 03/19/2018Terminated |
| Z-1511-2018 Class II | Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally…Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors… | 03/05/2018Terminated |
| Z-0669-2018 Class II | LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini…May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the… | 08/07/2017Terminated |
| Z-2051-2015 Class II | TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX…A specific part and lot number was packaged and shipped prior to the completion of a required internal… | 06/03/2015Terminated |
| Z-2092-2015 Class II | Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile…It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when… | 05/28/2015Terminated |
| Z-1799-2015 Class II | Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with…Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect… | 05/28/2015Terminated |
| Z-1915-2015 Class II | DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm…certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A… | 05/27/2015Terminated |
| Z-1800-2015 Class II | 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated…Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have… | 05/13/2015Terminated |
| Z-1711-2015 Class II | 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm…affected parts and lots of the Cannulated Drill Bits have the potential to break during use | 05/13/2015Terminated |
| Z-1600-2015 Class II | TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in…TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail.… | 04/09/2015Terminated |
| Z-1352-2015 Class II | Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and…The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of… | 02/24/2015Terminated |
| Z-1281-2015 Class II | Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX…For certain lots, the incorrect raw material of annealed 17-4PH Stainless Steel was used instead of the… | 02/17/2015Terminated |
| Z-1260-2015 Class II | Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails…The Inserter has the potential for mechanical failures such as breakage of the main shaft of the Inserter… | 02/03/2015Terminated |
| Z-1313-2015 Class II | Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for…In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive… | 12/19/2014Terminated |
| Z-1021-2015 Class II | 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be…Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and… | 12/15/2014Terminated |
| Z-0973-2015 Class II | Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft…Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured… | 12/15/2014Terminated |
| Z-0219-2015 Class II | 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile:…The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled… | 10/29/2014Terminated |
| Z-1009-2015 Class II | The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004…Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer… | 10/17/2014Terminated |
| Z-0092-2015 Class II | DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715Particle residue on the instrument from adhesive tape which was used to bind the device during transport.… | 10/02/2014Terminated |
| Z-2674-2014 Class II | DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184…DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Plates, which… | 09/02/2014Terminated |
| Z-2265-2014 Class II | Synthes 3.0 MM TI Cannulated Screw Instrument and Implant SetA screw set was returned from the field for destruction after being exposed to flood water, which was… | 06/30/2014Terminated |
| Z-2087-2014 Class II | Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate…The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be… | 05/29/2014Terminated |
| Z-1984-2014 Class II | Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part…All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not… | 05/15/2014Terminated |
| Z-1669-2014 Class II | Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm…Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use. | 04/29/2014Terminated |
| Z-1781-2014 Class II | Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate…It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the… | 04/22/2014Terminated |
| Z-2148-2014 Class I | DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC…DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB… | 04/16/2014Terminated |
| Z-1833-2014 Class II | Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance…Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes… | 04/10/2014Terminated |
| Z-1681-2014 Class II | Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL…Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect… | 04/08/2014Terminated |
| Z-1457-2014 Class II | The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to…The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of… | 02/11/2014Terminated |
| Z-1125-2014 Class II | Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking…Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior… | 02/05/2014Terminated |
| Z-1456-2014 Class II | Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the…The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, taps… | 01/30/2014Terminated |
| Z-1174-2014 Class II | Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch…Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by… | 01/27/2014Terminated |
| Z-0992-2014 Class II | Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial…One lot of Matrix Mandible Short Threaded Drill Guides (part No. 03.503.043) has a gray colored band instead… | 01/27/2014Terminated |
| Z-0986-2014 Class II | Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag…Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label. | 01/27/2014Terminated |
| Z-1274-2014 Class II | Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of…The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking… | 01/07/2014Terminated |
| Z-1057-2014 Class II | Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN…The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled… | 01/07/2014Terminated |
| Z-1094-2015 Class II | Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the…Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead of Revision… | 01/06/2012Terminated |
| Z-0489-2007 | LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius…Hole is malformed, leading to reduced construct strength. | 12/05/2006Terminated |