Recall archive
26 recalls · page 1 of 2
Reported Jan 8, 2014
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details · Reason for recall — 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"…
FDA (openFDA device enforcement)
Reported Dec 18, 2013
Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Osteotomy System" due to the potential for a surgical…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 11, 2013
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 4, 2013
2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand — 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.
15 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2013
Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2013
Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
FDA (openFDA device enforcement)
Reported Nov 6, 2013
Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which…
FDA (openFDA device enforcement)
Reported Oct 23, 2013
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt…
FDA (openFDA device enforcement)
Reported Oct 2, 2013
Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2013
Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.
FDA (openFDA device enforcement)
Reported Sep 4, 2013
Synthes Trauma Nail System. The devices are indication for bone fixation.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 21, 2013
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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Reason for recall — DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. This product was produced using a finishing process…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 7, 2013
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2013
Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 26, 2013
Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported May 15, 2013
Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — 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…
FDA (openFDA device enforcement)
Reported Apr 17, 2013
Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported Apr 3, 2013
Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Dens (odontoid process). There are currently no screws…
FDA (openFDA device enforcement)
Reported Mar 27, 2013
Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Mar 20, 2013
Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — 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"…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 13, 2013
Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 13, 2013
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — 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.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 21, 2012
Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product · Product details — The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched…
FDA (openFDA device enforcement)
Reported Oct 10, 2012
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes USA HQ, Inc.
Matched: Brand · Product details · Reason for recall — Synthes is initiating a Medical Device Labeling Correction following a detailed review of the current labeling in response to reported complaints.…
FDA (openFDA device enforcement)
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