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Synthes, Inc. Recalls

31 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Synthes, Inc..

31Total Recalls
0Critical
6.4MUnits Affected
Dec 16, 2019Most Recent
All Recalls

Every Synthes, Inc. Recall

Sorted by most recent. Click any recall for full details.

31 recalls
High RiskFDA
Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system t...
Medical Devices·25 affected·Dec 16, 2019
High RiskFDA
Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system t...
Medical Devices·25 affected·Dec 16, 2019
High RiskFDA
Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system t...
Medical Devices·25 affected·Dec 16, 2019
High RiskFDA
Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system t...
Medical Devices·25 affected·Dec 16, 2019
High RiskFDA
Synthes, Inc.
Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure t...
Medical Devices·84 affected·Mar 5, 2018
High RiskFDA
Synthes, Inc.
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleev...
Medical Devices·3,747 affected·May 28, 2015
High RiskFDA
Synthes, Inc.
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended...
Medical Implants·132,564 affected·May 28, 2015
High RiskFDA
Synthes, Inc.
DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur...
Medical Devices·276 affected·May 27, 2015
High RiskFDA
Synthes, Inc.
3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, os...
Medical Devices·54 affected·May 13, 2015
High RiskFDA
Synthes, Inc.
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 there is no indica...
Medical Devices·1,495 affected·May 13, 2015
High RiskFDA
Synthes, Inc.
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
Medical Devices·8,175 affected·Apr 9, 2015
High RiskFDA
Synthes, Inc.
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANC...
Medical Devices·131 affected·Feb 24, 2015
High RiskFDA
Synthes, Inc.
Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for ...
Medical Devices·183 affected·Feb 17, 2015
High RiskFDA
Synthes, Inc.
Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractur...
Medical Implants·1,550 affected·Feb 3, 2015
High RiskFDA
Synthes, Inc.
Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutti...
Surgical Devices·249 affected·Dec 19, 2014
High RiskFDA
Synthes, Inc.
Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used i...
Medical Devices·1,762 affected·Dec 15, 2014
High RiskFDA
Synthes, Inc.
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the ...
Medical Devices·6 affected·Oct 29, 2014
High RiskFDA
Synthes, Inc.
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Medical Devices·11 affected·Oct 2, 2014
High RiskFDA
Synthes, Inc.
DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level / 57 mm ...
Medical Devices·16 affected·Sep 2, 2014
High RiskFDA
Synthes, Inc.
Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instr...
Surgical Devices·44 affected·May 15, 2014
High RiskFDA
Synthes, Inc.
Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0...
Medical Implants·6,690 affected·Apr 29, 2014
High RiskFDA
Synthes, Inc.
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Medical Devices·5,114,052 affected·Apr 10, 2014
High RiskFDA
Synthes, Inc.
Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For...
Medical Devices·3 affected·Apr 8, 2014
High RiskFDA
Synthes, Inc.
The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
Medical Devices·20 affected·Feb 11, 2014
High RiskFDA
Synthes, Inc.
Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology in...
Medical Devices·45 affected·Feb 5, 2014
High RiskFDA
Synthes, Inc.
Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to ...
Medical Devices·20,081 affected·Jan 30, 2014
High RiskFDA
Synthes, Inc.
Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fix...
Medical Implants·18,747 affected·Jan 27, 2014
High RiskFDA
Synthes, Inc.
Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifica...
Medical Devices·12 affected·Jan 27, 2014
High RiskFDA
Synthes, Inc.
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Medical Devices·1,132,096 affected·Jan 27, 2014
High RiskFDA
Synthes, Inc.
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a ...
Medical Devices·143 affected·Jan 7, 2014
High RiskFDA
Synthes, Inc.
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Medical Implants·38 affected·Jan 6, 2012