FDA-Device2022-06-15Class II
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
Howmedica Osteonics Corp.
Hazard
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.
Sold states
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.
Affected count
22 units (12 US; 10 OUS)
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1237-2022Don't want to check this manually?
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