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Open, Classified

Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritanium Tibial Component (Size 5); Catalog Number 5536-B-500

FDA Recall Z-1237-2022 · Posted 2022-06-03

Recalling FirmHowmedica Osteonics Corp.
Recall StatusOpen, Classified
Product CodeJWH
Date Initiated2022-03-30
Product Quantity22 units (12 US; 10 OUS)

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.

Firm Action

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 [email protected]. ***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

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123486TRIATHLON TRITANIUM TIBIAL BASEPLATEStryker · 2013-05-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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