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.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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