Howmedica Osteonics Corp. Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritanium Tibial Component (Size 5); Catalog Number 5536-B-500 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.