Synthes Usa Hq recalls

Synthes Usa Hq appears in 56 official U.S. recall notices indexed by RecallRadar, most recently on 2014-01-08.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and w…
  FDA Device · Class II · 2014-01-08 · Synthes Usa Hq
  Reason: Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The "on" and "lock" labels were interchanged.
• Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable…
  FDA Device · Class II · 2013-12-18 · Synthes Usa Hq
  Reason: Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.
• Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal ti…
  FDA Device · Class II · 2013-12-18 · Synthes Usa Hq
  Reason: A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Osteotomy System" due to the potential for a surgical delay if the surgeon inserts the superior screws at a lesser angle (4 or…
• Synthes Soft Tissue Retractor Small Extendible
  FDA Device · Class II · 2013-12-11 · Synthes Usa Hq
  Reason: The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.
• Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur
  FDA Device · Class II · 2013-12-11 · Synthes Usa Hq
  Reason: Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.
• 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 anterior…
  FDA Device · Class II · 2013-12-11 · Synthes Usa Hq
  Reason: A potential non conformance was identified with the Zero-P VA plate where the screw could back out if the blocking mechanism is not visually confirmed to properly cover the head of the screw.
• Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
  FDA Device · Class II · 2013-12-04 · Synthes Usa Hq
  Reason: The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.
• Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthro…
  FDA Device · Class II · 2013-12-04 · Synthes Usa Hq
  Reason: All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension.
• Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended…
  FDA Device · Class II · 2013-12-04 · Synthes Usa Hq
  Reason: The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck.
• Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intende…
  FDA Device · Class II · 2013-12-04 · Synthes Usa Hq
  Reason: This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tight…
• Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Materia…
  FDA Device · Class II · 2013-12-04 · Synthes Usa Hq
  Reason: One material batch used for production of the affected parts of the Synthes Material Mix were mixed in with an incorrect material with a lower than specified hardness and corrosion resistance.
• Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechan…
  FDA Device · Class II · 2013-12-04 · Synthes Usa Hq
  Reason: Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction Insert malfunctioned causing pieces to break off. Once there is a breakage to the Reduction Insert it will not allow the in…
• Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to ben…
  FDA Device · Class II · 2013-12-04 · Synthes Usa Hq
  Reason: A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System.
• Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slip…
  FDA Device · Class II · 2013-12-04 · Synthes Usa Hq
  Reason: There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.
• 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusi…
  FDA Device · Class II · 2013-12-04 · Synthes Usa Hq
  Reason: Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.
• 3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking…
  FDA Device · Class II · 2013-12-04 · Synthes Usa Hq
  Reason: All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.
• Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readapta…
  FDA Device · Class II · 2013-12-04 · Synthes Usa Hq
  Reason: During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.
• Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medi…
  FDA Device · Class II · 2013-12-04 · Synthes Usa Hq
  Reason: Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.
• Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure
  FDA Device · Class II · 2013-12-04 · Synthes Usa Hq
  Reason: Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device.
• 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 buttr…
  FDA Device · Class II · 2013-12-04 · Synthes Usa Hq
  Reason: A plate was inadvertently released to a sales consultant that was restricted for sale.
• Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures
  FDA Device · Class II · 2013-12-04 · Synthes Usa Hq
  Reason: The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.
• Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation device…
  FDA Device · Class II · 2013-12-04 · Synthes Usa Hq
  Reason: This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tight…
• Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate…
  FDA Device · Class II · 2013-11-27 · Synthes Usa Hq
  Reason: The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened.
• Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to…
  FDA Device · Class II · 2013-11-27 · Synthes Usa Hq
  Reason: A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed.
• Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medic…
  FDA Device · Class II · 2013-11-20 · Synthes Usa Hq
  Reason: Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
• Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following ste…
  FDA Device · Class II · 2013-11-06 · Synthes Usa Hq
  Reason: When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.
• Synthes Midfoot Fusion Bolt 6.5 mm
  FDA Device · Class II · 2013-10-23 · Synthes Usa Hq
  Reason: A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasi…
• 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 dista…
  FDA Device · Class II · 2013-10-02 · Synthes Usa Hq
  Reason: Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).
• Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients wit…
  FDA Device · Class II · 2013-10-02 · Synthes Usa Hq
  Reason: This recall is being initiated in response to complaints received where it was reported that the proximal end of the Slap Hammer broke during use.
• Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile
  FDA Device · Class II · 2013-09-25 · Synthes Usa Hq
  Reason: Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.
• 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-articular…
  FDA Device · Class II · 2013-09-04 · Synthes Usa Hq
  Reason: The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with "R" for right plate when they should be etched with "L" for left plate.
• Synthes Trauma Nail System
  FDA Device · Class II · 2013-09-04 · Synthes Usa Hq
  Reason: Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be c…
• Synthes Flexible Medullary Reamer
  FDA Device · Class II · 2013-08-21 · Synthes Usa Hq
  Reason: Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the ope…
• 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 Unit Rod 370mm 5.0mm Unit Ro…
  FDA Device · Class II · 2013-08-21 · Synthes Usa Hq
  Reason: DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. This product was produced using a finishing process not identified as part of the manufacturing specification. No adverse e…
• Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to…
  FDA Device · Class II · 2013-08-07 · Synthes Usa Hq
  Reason: A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch instead of 18mm drill guide. The firm identified that this constituted a field action and retrospectively reported this act…
• Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixatio…
  FDA Device · Class II · 2013-08-07 · Synthes Usa Hq
  Reason: It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined t…
• Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for m…
  FDA Device · Class II · 2013-07-24 · Synthes Usa Hq
  Reason: Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and n…
• Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correctio…
  FDA Device · Class II · 2013-07-24 · Synthes Usa Hq
  Reason: The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots…
• Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
  FDA Device · Class II · 2013-06-26 · Synthes Usa Hq
  Reason: The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events.
• Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular syst…
  FDA Device · Class II · 2013-05-15 · Synthes Usa Hq
  Reason: The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result o…
• Flexible Grip which is part of the Synthes Universal Nail System
  FDA Device · Class II · 2013-04-17 · Synthes Usa Hq
  Reason: Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument.
• Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens ins…
  FDA Device · Class II · 2013-04-03 · Synthes Usa Hq
  Reason: The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Dens (odontoid process). There are currently no screws specifically indicated to treat Dens fractures via anterior screw fixa…
• Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431
  FDA Device · Class II · 2013-03-27 · Synthes Usa Hq
  Reason: It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree).
• Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072
  FDA Device · Class II · 2013-03-20 · Synthes Usa Hq
  Reason: Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.
• Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for…
  FDA Device · Class II · 2013-03-20 · Synthes Usa Hq
  Reason: The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.
• Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982
  FDA Device · Class II · 2013-03-20 · Synthes Usa Hq
  Reason: There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized.
• Synthes Multi-Vector Distractor Body, Part Number 487.931
  FDA Device · Class II · 2013-03-13 · Synthes Usa Hq
  Reason: It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
• Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967
  FDA Device · Class II · 2013-03-13 · Synthes Usa Hq
  Reason: It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
• Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966
  FDA Device · Class II · 2013-03-13 · Synthes Usa Hq
  Reason: It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
• Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012
  FDA Device · Class II · 2013-02-13 · Synthes Usa Hq
  Reason: Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.