Device product
6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Z-0139-2013
Product summary
- Event
- Event 63321
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0139-2013
Official wording
Reason: 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
Code information: Model Number 10-55-025, Lot Number 006A1057.
Distribution pattern: Nationwide Distribution only to CA.
Derived failure modes
-
Unknown
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