Synthes Usa (Hq), Inc.
West Chester, PA
This page shows every FDA and USDA recall linked to Synthes Usa (Hq), 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.
151
Total Recalls
2009
First Recall
2013
Most Recent
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012
The Synthes Electric Pen Drive is indicated...
Dec 31, 2013
· Device
Terminated
Synthes TomoFix Plates
The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteoto...
Dec 10, 2013
· Device
Terminated
Synthes Trochanteric Fixation Nail
As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN N...
Dec 10, 2013
· Device
Terminated
Synthes Zero-P VA Implant 7 MM Height Parallel Sterile
The Synthes Zero-P VA Implant 7 MM Height Parallel Ste...
Dec 5, 2013
· Device
Terminated
Titanium Trochanteric Fixation Nail (TFN)System
Intended to treat stable and unstable fractures of the proxim...
Dec 5, 2013
· Device
Terminated
Synthes Soft Tissue Retractor Small Extendible.
Offset blade facilitates easy preparation of the epipereostea...
Nov 29, 2013
· Device
Terminated
Synthes Titanium Cannulated Humeral Nail
Intended to aid in the alignment and stabilization of humeral fract...
Nov 27, 2013
· Device
Terminated
Slipped Capital Femoral Epiphysis System
Product Usage: Intended for fracture fixation of large bones and l...
Nov 27, 2013
· Device
Terminated
Synthes Implant Holder for Synfix (TM)-LR
the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand...
Nov 27, 2013
· Device
Terminated
Synthes 4.5 mm LCP Curved Condylar Plate
Intended for buttressing multifragmentary distal femur fractures.
Nov 27, 2013
· Device
Terminated
Vertebroplasty Needle Kit 10g Diamond Tip
Intended to be used to inject PMMA cement into vertebral bodies du...
Nov 27, 2013
· Device
Terminated
Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502
Non-cervical s...
Nov 26, 2013
· Device
Terminated
Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500
Non-c...
Nov 26, 2013
· Device
Terminated
Synthes Matrix 5.5.mm Left and Right Coronal Bender
Product Usage: The Matrix 5.5.mm Left and Right Coronal...
Nov 26, 2013
· Device
Terminated
Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Impl...
Nov 26, 2013
· Device
Terminated
3.7mm and 5.0mm Dynamic Locking Screw (DLS)
Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in...
Nov 26, 2013
· Device
Terminated
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/15...
Nov 26, 2013
· Device
Terminated
Synthes Spiked Washers 13.5/6.5
Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or f...
Nov 26, 2013
· Device
Terminated
Synthes Tensioning Device
The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation...
Nov 25, 2013
· Device
Terminated
Large Buttress Compression Nut For Blade Guide Sleeve TFN
The Synthes Large Buttress Compression Nut For Bla...
Nov 25, 2013
· Device
Terminated
2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM
Fixation of fractures, osteotomies, nonun...
Nov 22, 2013
· Device
Terminated
Synthes Matrix Threaded Persuader
Deformity is a comprehensive thoracolumbar pedical screw system designed to...
Nov 22, 2013
· Device
Terminated
Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade
Synthes Titanium Trochanteric Fixation Nail (...
Nov 20, 2013
· Device
Terminated
Synthes Soft Tissue Retractor Small Extendible
Offset blade facilitates easy preparation of the epipereosteal...
Nov 18, 2013
· Device
Terminated
Synthes 8.5 MM Medullary Reamer
Product Usage:
An orthopedic manual surgical instrument is a nonpowered hand...
Nov 13, 2013
· Device
Terminated
Synthes Application Instrument Sternal Zip Flex System
intended for use in primary or secondary closure/repai...
Oct 30, 2013
· Device
Terminated
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusio...
Oct 17, 2013
· Device
Terminated
Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847
The Oracle Spacer is ind...
Sep 26, 2013
· Device
Terminated
Synthes 3.5 MM LCP(R) Distal Humerus System
The Synthes 3.5 MM LCP Distal Humerus System is intended for fixa...
Sep 25, 2013
· Device
Terminated
Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant...
Sep 18, 2013
· Device
Terminated
Synthes Trauma Nail System. The devices are indication for bone fixation.
Aug 26, 2013
· Device
Terminated
Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right
Product Usage: Intended for fixation of co...
Aug 26, 2013
· Device
Terminated
Synthes Flexible Medullary Reamer.
Intended to be used to facilitate the preparation of the intramedullary ca...
Aug 12, 2013
· Device
Terminated
5.0mm Unit Rod 270mm
5.0mm Unit Rod 290mm
5.0mm Unit Rod 310mm
5.0mm Unit Rod 330mm
5.0mm Unit Rod 350mm
5.0mm...
Aug 9, 2013
· Device
Terminated
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599...
Jul 29, 2013
· Device
Open, Classified
Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900
Indicated for Hooks, Plate/Rods, Ro...
Jul 29, 2013
· Device
Terminated
Multi Vector Distractor Pin Holding Clamp, limited bone stock
The holding clamp is part of the Multi Vector D...
Jul 17, 2013
· Device
Terminated
Synthes CMF Distraction System
The product is intended for use as a bone stabilizer and lengthening (and/or t...
Jul 12, 2013
· Device
Terminated
Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
Jun 19, 2013
· Device
Terminated
Synthes Radial Head Prosthesis: Trial Radial Head
Elbow joint prosthesis: Synthes Radial Head Prosthesis Syst...
May 3, 2013
· Device
Terminated
Flexible Grip which is part of the Synthes Universal Nail System.
Indicated for the conventional (non-locking...
Apr 5, 2013
· Device
Terminated
Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retrac...
Mar 28, 2013
· Device
Terminated
Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431.
Indicated...
Mar 15, 2013
· Device
Terminated
Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gra...
Mar 12, 2013
· Device
Terminated
Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072.
Inte...
Mar 11, 2013
· Device
Terminated
Large Combination Clamp/Large External Fixation System, Part Number 390.005
Product Usage: Synthes Large Ext...
Mar 11, 2013
· Device
Terminated
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967.
For mandibular...
Mar 1, 2013
· Device
Terminated
Synthes Multi-Vector Distractor Body, Part Number 487.931.
For mandibular bone lengthening.
Mar 1, 2013
· Device
Terminated
Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966.
For mandibular...
Mar 1, 2013
· Device
Terminated
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill...
Feb 4, 2013
· Device
Terminated