6.5mm Cancellous Bone Screw Intended to be used for the recall
6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Why was 6.5mm Cancellous Bone Screw Intended to be used for the 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number 10-55-025, Lot Number 006A1057.
- Product
- 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
- Recalling firm
- Encore Medical, Lp
- Quantity
- 1 unit
- Distribution
- Nationwide Distribution only to CA.
- Recall date
- October 31, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)