Synthes, Inc.
West Chester, PA
This page shows every FDA and USDA recall linked to Synthes, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
43
Total Recalls
2012
First Recall
2020
Most Recent
MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facia...
Jun 18, 2020
· Device
Terminated
2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packag...
Dec 16, 2019
· Device
Terminated
2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packag...
Dec 16, 2019
· Device
Terminated
2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packag...
Dec 16, 2019
· Device
Terminated
2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packag...
Dec 16, 2019
· Device
Terminated
2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packag...
Dec 16, 2019
· Device
Terminated
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shou...
Mar 19, 2018
· Device
Terminated
Flex Arm
Product Usage:
The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System,...
Mar 5, 2018
· Device
Terminated
LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001
Used in LCP Modular Mini Fragment System, for f...
Aug 7, 2017
· Device
Terminated
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, steril...
Jul 16, 2015
· Device
Terminated
TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail Sy...
Jul 8, 2015
· Device
Terminated
DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part...
Jun 26, 2015
· Device
Terminated
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is pla...
Jun 15, 2015
· Device
Terminated
3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated fo...
Jun 15, 2015
· Device
Terminated
3.2 mm Cannulated Drill Bit/ QC 170 mm
2.7 Cannulated Drill Bit/ QC 160 mm
2.0 mm Cannulated Drill Bit / QC 1...
Jun 4, 2015
· Device
Terminated
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
May 12, 2015
· Device
Terminated
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm a...
Mar 30, 2015
· Device
Terminated
Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin...
Mar 23, 2015
· Device
Terminated
Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.04...
Mar 16, 2015
· Device
Terminated
Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fix...
Mar 10, 2015
· Device
Terminated
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding fro...
Feb 11, 2015
· Device
Terminated
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143)
Intended to be used for bending and/or...
Jan 28, 2015
· Device
Terminated
The Synthes Mandible External Fixator; all lots of part nos.:
04.305.003
04.305.004
04.305.005
04.305.010
04...
Jan 23, 2015
· Device
Terminated
Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of troc...
Jan 14, 2015
· Device
Terminated
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and...
Nov 14, 2014
· Device
Terminated
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Oct 20, 2014
· Device
Terminated
DePuy Synthes TI Vectra Plates:
TI Vectra-One" Plate 2 Level / 34 mm
part 04.613.184
3337672
TI Vectra" Pl...
Sep 22, 2014
· Device
Terminated
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
Aug 20, 2014
· Device
Terminated
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Aug 19, 2014
· Device
Terminated
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgic...
Jul 21, 2014
· Device
Terminated
Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and...
Jul 2, 2014
· Device
Terminated
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Jun 19, 2014
· Device
Terminated
Synthes Matrix Mandible Short Cut Plate Cutter
Synthes Matrix Mandible Short Cut Plate Cutter is intended fo...
Jun 11, 2014
· Device
Terminated
Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral bod...
Jun 2, 2014
· Device
Terminated
Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33...
May 29, 2014
· Device
Terminated
The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm
Product Usage: Used to expose bone for proce...
Apr 15, 2014
· Device
Terminated
Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to...
Apr 14, 2014
· Device
Terminated
Drill Template and the Saw Guide for the Ulna Osteotomy System.
Intended for fixation of fractures, osteotomi...
Mar 25, 2014
· Device
Terminated
Synthes Small Notch Titanium Reconstructive Plate
Product Usage:
The Synthes Small Notch Titanium Reconstruct...
Mar 11, 2014
· Device
Terminated
Synthes 5.0mm Variable Locking Screw
This device is part of the Variable Angle Locking Compression Plate fami...
Mar 4, 2014
· Device
Terminated
Synthes Driving Cap/Threaded
Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their...
Feb 20, 2014
· Device
Terminated
Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and recons...
Feb 19, 2014
· Device
Terminated
Synthes 3.2 mm Guide Wire 400mm.
Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Feb 16, 2014
· Device
Terminated