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Howmedica Osteonics Corp. Recall 90241

Description: 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. Recall 90241 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1237-2022
Event ID90241
Event DescriptionTriathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
Product TypeDevices
DistributionWorldwide 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.
Quantity22 units (12 US; 10 OUS)
Recall ReasonStryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.
Device Classification20220615
Device Code InfoCatalog Number UDI-DI (GTIN) Lots 5536-B-600 07613327041514 CTD69463 5536-B-500 07613327041507 CTD69106
Center Classification Date20220603
Recall Initiation Date20220330
Recalling FirmHowmedica Osteonics Corp.
Initial Notification Letter
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