Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd.,
FDA device recall Z-1010-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Encore Medical, LP
- Reason for recall
- Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE
- Action taken
- The firm sent recall letters to all consignees on May 10, 2004 requesting return of the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 15
- Distribution
- Product was distributed domesically to the following states: IA, MA, OK, TX, FL, CA, and SD. Product was shipped to one distributor in Germany.
- Date initiated
- 2004-05-10
- Date posted
- 2004-07-20
- Date terminated
- 2004-08-09
- 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 KNEE SYSTEM (K923277) | Encore Orthopedics, Inc. | 1993-02-09 |