Reported Nov 21, 2012 · Terminated
Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for…
Synthes USA HQ, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes USA HQ, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically
- the components can be used forStabilization of soft tissues and fractures; Polytrauma/multiple orthopedic trauma; Vertically stable pelvic fractures, or as treatment adjunct for vertically unstable pelvic fractures; Arthrodeses and osteotomies with soft tissue problems - failures of total joints; Neutralization of fractures stabilized with limited internal fixation; Non-unions/septic non-unions; Intra-operative reductions/stabilization tool to assist with indirect reduction; and Unilateral rectilinear bone segment transport or leg lengthening
- Lot codes and dates
Part number 390.007Lot number 6800599
- Amount recalled
- 8
Where it was sold
Why it was recalled
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 as MR Conditional. The insert is incorrect.
This product could cause temporary or reversible health problems — stop using it.
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