FDA Device Recalls

Recalls / Firms / Synthes USA HQ, Inc.

Synthes USA HQ, Inc.

151 FDA device recalls on record.

DateClassProductReason
2013-10-15Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Rem
2013-10-09Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wed
2013-10-08Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-po
2013-10-03Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixat
2013-10-03Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpo
2013-10-03Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattac
2013-09-30Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Pa
2013-09-24Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epi
2013-08-13Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary clo
2013-08-01Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the ep
2013-07-312.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotom
2013-07-31Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system d
2013-07-31Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture
2013-07-31Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression N
2013-07-31Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large b
2013-07-30Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of hum
2013-07-30Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System,
2013-07-30Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of
2013-07-30Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixa
2013-07-30Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral
2013-07-30Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fr
2013-07-223.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw
2013-06-22Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Rig
2013-06-12Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening
2013-06-11Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intrame
2013-06-055.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 3
2013-05-31Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Mult
2013-05-29Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar P
2013-04-18Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthpped
2013-04-15Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is
2013-03-08Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions,
2013-03-08Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intende
2013-02-22Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
2013-02-22Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prost
2013-01-11Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Col
2013-01-11Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For
2013-01-11Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431.
2013-01-11Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilizati
2013-01-11Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes
2013-01-11Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spa
2013-01-11Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
2013-01-11Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.
2013-01-11Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (n
2013-01-11Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For
2012-11-02Synthes Trauma Nail System. The devices are indication for bone fixation.
2012-10-12Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number
2012-10-12Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plat
2012-09-28Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provi
2012-09-07Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.
2012-09-07Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-
2012-08-06Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjust
2012-08-06Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5m
2012-07-05Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.90
2012-06-18MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrument
2012-05-224.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or
2012-05-224.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or
2011-11-02Synthes Drill Bit for 5.0mm Recon Screws with Large Quick Coupling. This orthopedic manual surgical
2011-10-17Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical instrument mo
2011-09-23Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. Trans
2011-09-23Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody fusion (AC
2011-03-11Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000. Intended for po
2011-01-26Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes) Indicate
2010-10-2702.122.570S, 70mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.621S, 120mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.591S, 90mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.595S, 95mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.600S, 100mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthe
2010-10-2702.122.590S, 90mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.620, 120mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.565, 65mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.561S, 60mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.586S, 85mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.555S, 55mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.585, 85mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.580S, 80mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.550S, 50mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.551, 50mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Bl
2010-10-2702.122.596S, 95mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.605, 105mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.611S, 110mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.565S, 65mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.590, 90mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.606, 105mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.566S, 65mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.616, 115mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.600, 100mm Spiral Blade, 14mm, Right- Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.611, 110mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.621, 120mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.601S, 100mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.581, 80mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular B
2010-10-2702.122.591, 90mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular B
2010-10-2702.122.575, 75mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.606S, 105mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.551S, 50mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes M
2010-10-2702.122.555, 55mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular B
2010-10-2702.122.556S, 55mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.576, 75mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.610, 110mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.610s, 110mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthe
2010-10-2702.122.585S, 85mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.571S, 70mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.586, 85mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular B
2010-10-2702.122.620S, 120mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthe
2010-10-2702.122.575S, 75mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.615, 115mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.601, 100mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.596, 95mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular B
2010-10-2702.122.605S, 105mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthe
2010-10-2702.122.581S, 80mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.576S, 75mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.556, 55mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular B
2010-10-2702.122.615S, 115mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthe
2010-10-2702.122.571, 70mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular B
2010-10-2702.122.616S, 115mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes
2010-10-2702.122.580, 80mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.550, 50mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular B
2010-10-2702.122.570, 70mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.566, 65mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular B
2010-10-2702.122.595, 95mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular
2010-10-2702.122.561, 60mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular B
2010-09-163.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and fracture dislocations, o
2010-07-23SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) Th
2010-04-01Synthes Medullary Tubes
2010-02-257.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number 462.723S Synthes Titanium Solid Humeral N
2010-02-257.5mm Ti Solid Humeral Nail 250 mm Sterile Catalog number 462.725S Synthes Titanium Solid Humeral N
2010-01-06Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S.
2009-09-14Synthes USA, TI Synex (TM) II Central Body 58mm - 84mm, Catalog number 04.808.008. Intended for use
2009-09-14Synthes USA, TI Synex (TM) II Central Body 21mm - 29mm, Catalog number 04.808.003. Intended for use
2009-09-14Synthes USA, TI Synex (TM) II Central Body 29mm - 44mm, Catalog number 04.808.005. Intended for use
2009-09-14Synthes USA, TI Synex (TM) II Central Body 71mm - 97mm, Catalog number 04.808.009. Intended for use
2009-09-14Synthes USA, TI Synex (TM) II Central Body 97mm - 123mm, Catalog number 04.808.011. Intended for us
2009-09-14Synthes USA, TI Synex (TM) II Central Body 45mm - 71mm, Catalog number 04.808.007. Intended for use
2009-09-14Norian CRS Rotary Mixer Cement 10cc sterile
2009-09-14Synthes USA, TI Synex (TM) II Central Body 84mm - 110mm, Catalog number 04.808.010. Intended for us
2009-09-14Synthes USA, TI Synex (TM) II Central Body 17mm - 25mm, Catalog number 04.808.002. Intended for use
2009-09-14Synthes USA, TI Synex (TM) II Central Body 37mm - 52mm, Catalog number 04.808.006. Intended for use
2009-09-14Synthes USA, TI Synex (TM) II Central Body 25mm - 33mm, Catalog number 04.808.004. Intended for use
2009-09-14Synthes USA, TI Synex (TM) II Central Body 14mm - 19mm, Catalog number 04.808.001. Intended for use
2009-09-03SYNTHES 2.0MM SCREW MANIPULATION FORCEPS, Catalog #SD397.300. Synthes Titanium Matrix Mandible Sagi
2009-09-03SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/42MM, Catalog # SD448.004. Synthes Titaniu
2009-09-03SYNTHES BENDING PLIERS - STRAIGHT FOR CRANIOFACIAL/ORTHOGNATHIC PL, Catalog # SD347.967. Synthes Ti
2009-09-03SYNTHES 2.0MM DRILL BIT STRYKER J-LATCH/60MM, Catalog # 317.853. Synthes Titanium Matrix Mandible S
2009-09-03SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/39MM, Catalog # SD448.003. Synthes Titaniu
2009-09-03SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/48MM, Catalog # SD448.006. Synthes Titaniu
2009-09-03SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/45MM, Catalog # SD448.005. Synthes Titaniu
2009-09-03SYNTHES PLATE HOLDING FORCEPS, Catalog # SD347.900
2009-02-09NFix II System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobilization and
2009-02-09NFlex Straight monosegmental L 150mm The Synthes N-Hance and NFix II rods are intended to provide im
2009-02-09N-Hance System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobilization and
2009-02-09TI N-Hance Rod 150mm Sterile The Synthes N-Hance and NFix II rods are intended to provide immobiliza
2009-02-09NFlex Stabilization System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobi