Recall archive
59 recalls · page 3 of 3
Reported Sep 9, 2015
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — The last hole on certain VEPTR Inferior Cradles may be partially formed. Fully lengthening the construct to the partially formed last hole may result…
FDA (openFDA device enforcement)
Reported Sep 2, 2015
Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2015
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — Potential for micropores to form, allowing fluid to enter the hollow handle.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2015
8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material:…
FDA (openFDA device enforcement)
Reported Aug 5, 2015
Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate /…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation.
FDA (openFDA device enforcement)
Reported Jul 22, 2015
16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 14, 2015
Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Unintended start of…
FDA (openFDA device enforcement)
Reported Dec 3, 2014
Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped.…
FDA (openFDA device enforcement)
Reported Dec 4, 2013
Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 4, 2013
Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting…
FDA (openFDA device enforcement)
Reported Aug 1, 2012
Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong part number - 498.321 (Lamina Hook, Medium, Left). The…
FDA (openFDA device enforcement)
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