Triathlon Total Knee system Primary Tibial Baseplate #5 Beaded wPA; Catalog Number 5526-B-500, Cementless use only. Ster
FDA device recall Z-0579-2009 · posted 2009-01-08 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker Orthopaedics became aware that one lot of the Triathlon Primary Beaded PA Baseplate Size 5 may not have the Peri-Apatite coating.
- Action taken
- Important Market Withdrawal notification letters were sent via Fed Ex on 9/20/06 to the direct accounts. Notification letters informed of the reason for the market withdrawal and requested that all branches examine their inventory and hospital consignment locations to identify the product. Product was to be reconciled on the Product Accountability Form and returned to Stryker as per instructions. Contact Stryker Howmedica Osteonics Corp at 1-201-831-5718 for assistance.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- MBH
- Quantity affected
- 10
- Distribution
- PA, GA, AL, WI, UT, and OR.
- Date initiated
- 2006-09-21
- Date posted
- 2009-01-08
- Date terminated
- 2009-01-09
- 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 |
|---|---|---|
| TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM (K051380) | Howmedica Osteonics Corp. | 2005-08-30 |