Data Foundry

Medical device recalls 2022

Triathlon Tritanium Tibial Component — Class II medical device recall Z-1237-2022

Ongoing recall by Howmedica Osteonics Corp., reported 2022-06-15, distributed nationwide. Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component insi

Recall numberZ-1237-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmHowmedica Osteonics Corp., Mahwah, NJ, United States
Recall initiated2022-03-30
Classified2022-06-03
Reported by FDA2022-06-15
DistributedNationwide (US)
Countries outside the USGB, PL
Reason classeslabeling
UPC / GTIN / UDI-DI07613327041507, 07613327041514
Lot numbers5536-B-500, 5536-B-600, CTD69106, CTD69463
Model numbers07613327041507, 07613327041514, 5536-B-500, 5536-B-600, CTD69106, CTD69463

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1237-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.