Reported Oct 31, 2012 · Terminated
6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Encore Medical, LP
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: Encore Medical, Lp · 9800 Metric Blvd · Austin, TX · 78758
Is this the product you have?
- 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
- Lot codes and dates
Model Number 10-55-025Lot Number 006A1057
- Amount recalled
- 1 unit
Where it was sold
- Nationwide
- CA
Why it was recalled
A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contained, but it was determined later that on
This product could cause temporary or reversible health problems — stop using it.
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