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Recall Observatory FDA recall evidence

Device product

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

Z-1237-2022

March 30, 2022

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 90241
Status
Ongoing
Classification
Class II
Quantity
22 units (12 US; 10 OUS)
Official record key
device-enforcement:Z-1237-2022

Official wording

Reason: 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.

Code information: Catalog Number UDI-DI (GTIN) Lots 5536-B-600 07613327041514 CTD69463 5536-B-500 07613327041507 CTD69106

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.