Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (p
FDA device recall Z-2360-2015 · posted 2015-08-10 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert.
- Action taken
- Stryker Orthopaedics sent an Urgent Medical Device Recall Notification letter dated July 9, 2015 and Product Accountability Forms via return receipt. The letter identified the affected product, problem, potential hazard, risk mitigation and actions to be taken. Contact Stryker Orthopaedics Sales Representative to arrange for return of the affected product. For questions call 201-831-5826.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 26 units
- Distribution
- Worldwide Distribution - US Nationwide
- Date initiated
- 2015-05-29
- Date posted
- 2015-08-10
- Date terminated
- 2016-07-25
- 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 KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS (K141056) | Stryker Orthopaedics | 2014-08-05 |