Howmedica Osteonics Corp.: Medical Device Recall in 2022 - (Recall #: Z-1237-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 30, 2022

Date Posted: June 15, 2022

Recall Number: Z-1237-2022

Event ID: 90241

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.

Status: Ongoing

Product Quantity: 22 units (12 US; 10 OUS)

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.

Voluntary or Mandated:

Voluntary: Firm initiated