Synthes, Inc.

Complete recall history across all FDA and CPSC categories — 43 total recalls

Synthes, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (43)

FDA medical device enforcement actions by Synthes, Inc.

Date Product Reason Class
Jun 18, 2020 MatrixNEURO Screws - Product Usage: The intended use for this device is in fi... One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", whi... Class II
Dec 16, 2019 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - ... There is a possibility that the inner cap could open when the outer cap is re... Class II
Dec 16, 2019 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - ... There is a possibility that the inner cap could open when the outer cap is re... Class II
Dec 16, 2019 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - ... There is a possibility that the inner cap could open when the outer cap is re... Class II
Dec 16, 2019 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - ... There is a possibility that the inner cap could open when the outer cap is re... Class II
Dec 16, 2019 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - ... There is a possibility that the inner cap could open when the outer cap is re... Class II
Mar 19, 2018 Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extr... There is a potential for the connection screw of the stem extractor to break. Class II
Mar 5, 2018 Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthe... Quick connect feature of instruments may be unable to connect to the male fea... Class II
Aug 7, 2017 LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP M... May have difficulty attaching the drill sleeve to the plate. If the drill sle... Class II
Jun 3, 2015 TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL... A specific part and lot number was packaged and shipped prior to the completi... Class II
May 28, 2015 Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, ... It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have... Class II
May 28, 2015 Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction ... Certain affected parts and lots of the Pull Reduction Devices may have been m... Class II
May 27, 2015 DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm... certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the ... Class II
May 13, 2015 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm ... affected parts and lots of the Cannulated Drill Bits have the potential to br... Class II
May 13, 2015 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the C... Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Coni... Class II
Apr 9, 2015 TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractur... TFNA nails from certain lots were assembled with a locking mechanism too clos... Class II
Feb 24, 2015 Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aimin... The guide sleeve has the potential to jam in the Aiming Arms, which may delay... Class II
Feb 17, 2015 Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femora... For certain lots, the incorrect raw material of annealed 17-4PH Stainless Ste... Class II
Feb 3, 2015 Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elasti... The Inserter has the potential for mechanical failures such as breakage of th... Class II
Dec 19, 2014 Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is in... In May 2013, the original recall was initiated due to complaints the Hand Swi... Class II
Dec 15, 2014 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Int... Certain lots have the potential for tip breakage while bending 2.0 mm thick p... Class II
Dec 15, 2014 Malleable C- Retractor, Part Number 397.232, used to provide retraction of th... Potential failure and/or corrosion of the internal spring of the retractor, w... Class II
Oct 29, 2014 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Ster... The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (S... Class II
Oct 17, 2014 The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 ... Under new testing protocols for MR Environment safety and compatibility, meta... Class II
Oct 2, 2014 DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715 Particle residue on the instrument from adhesive tape which was used to bind ... Class II
Sep 2, 2014 DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm par... DePuy Synthes is initiating a voluntary medical device recall of certain lots... Class II
Jun 30, 2014 Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set A screw set was returned from the field for destruction after being exposed t... Class II
May 29, 2014 Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius ... The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plat... Class II
May 15, 2014 Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming... All lots of B37 Replacement Screws are being recalled due to potential mislab... Class II
Apr 29, 2014 Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2... Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential ... Class II
Apr 22, 2014 Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Sh... It was discovered internally that the face of the Synthes Matrix Mandible Sho... Class II
Apr 16, 2014 DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies an... DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofaci... Class I
Apr 10, 2014 Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixatio... Labeling changes have been made related to MR (Magnetic Resonance imaging) co... Class II
Apr 8, 2014 Synthes XRL Medium Trial - Central Body, an instrument used as part of the Sy... Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly... Class II
Feb 11, 2014 The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Us... The Synthes Hohmann Retractor was mis-etched on the product and package as pa... Class II
Feb 5, 2014 Synthes 5.0mm Variable Locking Screw This device is part of the Variable A... Labeling correction: The package insert in one 5.0mm Variable Locking Screw p... Class II
Jan 30, 2014 Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws i... The CMF Battery Powered Driver graphic case contains outlines of the Battery... Class II
Jan 27, 2014 Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade an... Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on ... Class II
Jan 27, 2014 Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillo... One lot of Matrix Mandible Short Threaded Drill Guides (part No. 03.503.043) ... Class II
Jan 27, 2014 Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synt... Certain modules containing the Synthes Small Notch Titanium Reconstructive Pl... Class II
Jan 7, 2014 Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended f... The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibi... Class II
Jan 7, 2014 Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia ... The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertio... Class II
Jan 6, 2012 Hemostatic Bone Putty, for use as a water-soluble implant material and for u... Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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