Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritanium Tibial Component (Size 5); Catalog Number 5536-B-500
- Company
- Howmedica Osteonics Corp.
- Recall Initiated
- March 30, 2022
- Posted
- June 3, 2022
- Recall Number
- Z-1237-2022
- Quantity
- 22 units (12 US; 10 OUS)
- Firm Location
- Mahwah, NJ
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.
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.
Lot / Code Info
Catalog Number UDI-DI (GTIN) Lots 5536-B-600 07613327041514 CTD69463 5536-B-500 07613327041507 CTD69106
Root Cause
Under Investigation by firm
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.