Triathlon X3 Total Stabilizer + Tibial Insert For use with Triathlon Universal Baseplates, knee prosthesis. #5 13mm Stry
FDA device recall Z-1231-2007 · posted 2007-09-25 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stabilizer posts, packaged with the Triathlon TS Plus Tibial inserts have a specification anomaly related to length, resulting in a potential for the post to slightly protrude above the top surface of the plastic post.
- Action taken
- Recall notification letters and product acknowledgment forms were send via Federal Express on August 2, 2007.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 14
- Distribution
- Product distributed to 5 hospitals in GA, OH, MN, TX.
- Date initiated
- 2007-07-31
- Date posted
- 2007-09-25
- Date terminated
- 2007-12-05
- 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 TS KNEE SYSTEM (K070095) | Howmedica Osteonics Corp. | 2007-06-01 |