Z-1237-2022 Class II Ongoing
FDA device recall Z-1237-2022 was initiated by Howmedica Osteonics Corp. on Mar 30, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 22 units (12 US; 10 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Jun 15, 2022
- Initiation Date
- Mar 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 units (12 US; 10 OUS)
Product Description
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
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.
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.
Code Information
Catalog Number UDI-DI (GTIN) Lots 5536-B-600 07613327041514 CTD69463 5536-B-500 07613327041507 CTD69106
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1237-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026