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All Recalls

Every Synthes Usa Hq, Inc. Recall

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

29 recalls
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Ma...
Medical Implants·44 affected·Oct 15, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for...
Medical Implants·548 affected·Oct 8, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone ant...
Medical Implants·1 affected·Sep 30, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum followin...
Medical Devices·319 affected·Aug 13, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous...
Medical Devices·374 affected·Aug 1, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudo...
Medical Devices·369 affected·Jul 31, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is in...
Medical Devices·135 affected·Jul 31, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and f...
Medical Devices·166 affected·Jul 31, 2013
High RiskFDA
Synthes Usa Hq, Inc.
2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and f...
Medical Devices·98 affected·Jul 31, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty proce...
Medical Devices·40 affected·Jul 30, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
Medical Devices·17 affected·Jul 30, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
Medical Devices·14 affected·Jul 30, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-art...
Medical Devices·11 affected·Jul 30, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for bu...
Medical Implants·1 affected·May 29, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
Medical Implants·1 affected·Apr 18, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the ...
Medical Devices·2 affected·Mar 8, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the fo...
Medical Devices·62 affected·Mar 8, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Den...
Medical Devices·148 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise a...
Medical Devices·18 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
Medical Devices·18 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced ...
Medical Devices·4 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
Medical Devices·2 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating s...
Medical Devices·328 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fi...
Medical Devices·8 affected·Oct 12, 2012
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation d...
Medical Devices·757 affected·Sep 7, 2012
CriticalFDA
Synthes Usa Hq, Inc.
Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. Indicated ...
Medical Implants·8,853 affected·Jul 5, 2012
High RiskFDA
Synthes Usa Hq, Inc.
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. ...
Medical Devices·1,602 affected·Jun 18, 2012
High RiskFDA
Synthes Usa Hq, Inc.
4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101...
Medical Devices·20 affected·May 22, 2012
High RiskFDA
Synthes Usa Hq, Inc.
4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101...
Medical Devices·20 affected·May 22, 2012