Duracon Total Knee, A-P Lipped Tibial Insert; 11MM Sterile; Howmedica Osteonics Corp. Stryker, Ireland. Product No. 6642
FDA device recall Z-1601-2009 · posted 2009-07-07 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- A box packaged and labeled as a Duracon Total Knee Duration A-P Lipped Tibial Insert 11MM may actually contain a 9MM insert.
- Action taken
- A notification letter and product accountability form were sent via Federal Express on May 5, 2006 with return receipt to branch accounts that had received the affected product. For questions about the recall contact Stryker Howmedica Osteonics Corp. by calling 1-201-831-5000.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 8
- Distribution
- Nationwide Distribution (AL, OH, MN, NM, and CA).
- Date initiated
- 2006-05-05
- Date posted
- 2009-07-07
- Date terminated
- 2009-07-07
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS (K915512) | Pfizer Hospital Products Group, Inc. | 1992-08-18 |