Browse Device Recalls

43 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 43 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 43 FDA device recalls.

Clear

Date	Product	Reason	Class	Firm
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", which indicated a 4mm s...	Class II	Synthes, Inc.
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 removed or the entire ...	Class II	Synthes, Inc.
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 removed or the entire ...	Class II	Synthes, Inc.
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 removed or the entire ...	Class II	Synthes, Inc.
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 removed or the entire ...	Class II	Synthes, Inc.
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 removed or the entire ...	Class II	Synthes, Inc.
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	Synthes, Inc.
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 features of Flex Arm Ad...	Class II	Synthes, Inc.
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 sleeve will not connect...	Class II	Synthes, Inc.
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 completion of a required int...	Class II	Synthes, Inc.
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 the potential to br...	Class II	Synthes, Inc.
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 manufactured to an in...	Class II	Synthes, Inc.
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 incorrect insert GP0...	Class II	Synthes, Inc.
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 break during use	Class II	Synthes, Inc.
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 Conical Screws were foun...	Class II	Synthes, Inc.
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 close to the top of the ...	Class II	Synthes, Inc.
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 disassembly and rem...	Class II	Synthes, Inc.
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 Steel was used instead ...	Class II	Synthes, Inc.
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 the main shaft of the ...	Class II	Synthes, Inc.
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 Switch for the Electric...	Class II	Synthes, Inc.
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 plates. If device is...	Class II	Synthes, Inc.
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, which may have been m...	Class II	Synthes, Inc.
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 (Sterile) was assemble...	Class II	Synthes, Inc.
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, metal devices are no lon...	Class II	Synthes, Inc.
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 the device during tr...	Class II	Synthes, Inc.
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 of the TI Vectra Pl...	Class II	Synthes, Inc.
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 to flood water, which...	Class II	Synthes, Inc.
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 Plate System) were found...	Class II	Synthes, Inc.
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 mislabeling where the pack...	Class II	Synthes, Inc.
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 to break during use.	Class II	Synthes, Inc.
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 Short Cut Plate Cutter ...	Class II	Synthes, Inc.
Apr 16, 2014	DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies an...	DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction Syste...	Class I	Synthes, Inc.
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) conditions as a result...	Class II	Synthes, Inc.
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 etched with the inc...	Class II	Synthes, Inc.
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 part number 399.24 ins...	Class II	Synthes, Inc.
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 package was a GP0006 ...	Class II	Synthes, Inc.
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 Powered Driver, tap...	Class II	Synthes, Inc.
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 the label.	Class II	Synthes, Inc.
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) has a gray colored b...	Class II	Synthes, Inc.
Jan 27, 2014	Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synt...	Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distribu...	Class II	Synthes, Inc.
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 exhibit jamming, bending, ...	Class II	Synthes, Inc.
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 Insertion Handles when assem...	Class II	Synthes, Inc.
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 consultants instead ...	Class II	Synthes, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.