Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement.
FDA device recall Z-0331-06 · posted 2005-12-29 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.
- Action taken
- Firm initiated recall on 11/03/05 via letter to all consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 16 units.
- Distribution
- Device distributed to direct accounts in AZ, CA, FL, GA, MO, NJ, OK, SC, SD and TX. Foreign consignies located in Freiburg and Langelsheim, Germany.
- Date initiated
- 2005-11-03
- Date posted
- 2005-12-29
- Date terminated
- 2008-04-04
- 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 |