Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551
FDA device recall Z-1255-2010 · posted 2010-04-07 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- One lot of product was incorrectly manufactured. Pegs are larger than specification.
- Action taken
- Firm notified consignees by e-mail on 2/22/2010.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 2 units
- Distribution
- United States (FL and ID).
- Date initiated
- 2010-02-22
- Date posted
- 2010-04-07
- Date terminated
- 2010-07-22
- 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 METAL-BACKED PATELLA (K932246) | Encore Orthopedics, Inc. | 1994-07-22 |