FDAFDA · Food and drugs·Recall number Z-0139-2013
6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Published October 31, 2012 · Recall initiated: September 28, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Encore Medical, Lp
- Distributor
- Nationwide Distribution only to CA.
- Lot
- Model Number 10-55-025, Lot Number 006A1057.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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