6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
FDA device recall Z-0139-2013 · posted 2012-10-25 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- 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
- Action taken
- Encore Medical sent a Urgent Field Safety Notice dated September 28, 2012, to all affected customers. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please contact Customer Service to place a replacement order and receive an RMA number. Return all affected devices using the RMA number. For further questions please call (512) 834-6255
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 1 unit
- Distribution
- Nationwide Distribution only to CA.
- Date initiated
- 2012-09-28
- Date posted
- 2012-10-25
- Date terminated
- 2013-01-25
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 6.5 MM CANCELLOUS BONE SCREW (K931665) | Encore Orthopedics, Inc. | 1994-02-17 |