Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left
FDA device recall Z-0826-2010 · posted 2010-02-24 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Partial lot of product was not manufactured to specification. Central locking screw was missing threads. There is a potential for dissociation because the screw is not able to be used as a secondary fixation method.
- Action taken
- Firm notified consignees by letter on 12/11/2009. The letter informs physicians that patients with implanted devices should counseled about the issue and should report any changes to their treating physician.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 17
- Distribution
- TX, FL, GA, CA, AZ, Japan
- Date initiated
- 2009-12-11
- Date posted
- 2010-02-24
- Date terminated
- 2010-09-24
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FOUNDATION MODULAR TIBIAL BASEPLATE (K932425) | Encore Orthopedics, Inc. | 1994-07-22 |