Synthes, Inc. recalls

24 recalls on record · latest: June 18, 2020

Official U.S. recall history for Synthes, Inc., compiled from official government records.

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Synthes, Inc. recalls MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleto…

June 18, 2020 · Medical device recalls Moderate risk One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which…

Synthes, Inc. recalls 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a…

December 16, 2019 · Medical device recalls Moderate risk There is a possibility that the inner cap could open when the outer cap is remo…

Synthes, Inc. recalls 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a…

December 16, 2019 · Medical device recalls Moderate risk There is a possibility that the inner cap could open when the outer cap is remo…

Synthes, Inc. recalls 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a…

December 16, 2019 · Medical device recalls Moderate risk There is a possibility that the inner cap could open when the outer cap is remo…

Synthes, Inc. recalls 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a…

December 16, 2019 · Medical device recalls Moderate risk There is a possibility that the inner cap could open when the outer cap is remo…

Synthes, Inc. recalls 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a…

December 16, 2019 · Medical device recalls Moderate risk There is a possibility that the inner cap could open when the outer cap is remo…

Synthes, Inc. recalls Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder impla…

March 19, 2018 · Medical device recalls Moderate risk There is a potential for the connection screw of the stem extractor to break.

Synthes, Inc. recalls Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which pro…

March 5, 2018 · Medical device recalls Moderate risk Quick connect feature of instruments may be unable to connect to the male featu…

Synthes, Inc. recalls LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of s…

August 7, 2017 · Medical device recalls Moderate risk May have difficulty attaching the drill sleeve to the plate. If the drill sleev…

Synthes, Inc. recalls TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX i…

June 3, 2015 · Medical device recalls Moderate risk A specific part and lot number was packaged and shipped prior to the completion…

Synthes, Inc. recalls Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed throu…

May 28, 2015 · Medical device recalls Moderate risk Certain affected parts and lots of the Pull Reduction Devices may have been man…

Synthes, Inc. recalls Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-…

May 28, 2015 · Medical device recalls Moderate risk It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have t…

Synthes, Inc. recalls DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Exp…

May 27, 2015 · Medical device recalls Moderate risk certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the in…

Synthes, Inc. recalls 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm ther…

May 13, 2015 · Medical device recalls Moderate risk affected parts and lots of the Cannulated Drill Bits have the potential to brea…

Synthes, Inc. recalls 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation…

May 13, 2015 · Medical device recalls Moderate risk Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conica…

Synthes, Inc. recalls TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

April 9, 2015 · Medical device recalls Moderate risk TFNA nails from certain lots were assembled with a locking mechanism too close…

Synthes, Inc. recalls Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part…

February 24, 2015 · Medical device recalls Moderate risk The guide sleeve has the potential to jam in the Aiming Arms, which may delay d…

Synthes, Inc. recalls Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and th…

February 17, 2015 · Medical device recalls Moderate risk For certain lots, the incorrect raw material of annealed 17-4PH Stainless Steel…

Synthes, Inc. recalls Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of…

February 3, 2015 · Medical device recalls Moderate risk The Inserter has the potential for mechanical failures such as breakage of the…

Synthes, Inc. recalls Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire…

December 19, 2014 · Medical device recalls Moderate risk In May 2013, the original recall was initiated due to complaints the Hand Switc…

Synthes, Inc. recalls Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instru…

December 15, 2014 · Medical device recalls Moderate risk Potential failure and/or corrosion of the internal spring of the retractor, whi…

Synthes, Inc. recalls 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting M…

December 15, 2014 · Medical device recalls Moderate risk Certain lots have the potential for tip breakage while bending 2.0 mm thick pla…

Synthes, Inc. recalls The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04…

October 17, 2014 · Medical device recalls Moderate risk Under new testing protocols for MR Environment safety and compatibility, metal…

Synthes, Inc. recalls Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone sur…

January 6, 2012 · Medical device recalls Moderate risk Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales co…