Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritanium Tibial Component (Size 5);
FDA device recall Z-1237-2022 · posted 2022-06-03 · Open, Classified
Recall details
- Recalling firm
- Howmedica Osteonics Corp.
- Reason for recall
- Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.
- Action taken
- On March 30, 2022, the firm sent Urgent Medical Device Recall letters to affected customers. Customers were instructed to immediately identify, quarantine, and discontinue use of any affected devices in their facility. Customers should return the devices back to Stryker. If you have any questions or concerns regarding this recall, please contact Customer Service at (201) 831-5000. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com. ***Updated 6/6/22*** On June 6, 2022, the firm sent an updated letter to affected customers. The update letter includes the hazards, harms, and risk mitigation.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 22 units (12 US; 10 OUS)
- Distribution
- Worldwide distribution - US Nationwide in the states of AL, CA, CO, ID, IN, KS, MI, NV, PA, TN, WA, and WV. The countries of UK and Poland.
- Date initiated
- 2022-03-30
- Date posted
- 2022-06-03
- 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 TRITANIUM TIBIAL BASEPLATE (K123486) | Stryker | 2013-05-03 |