FDA Device recall Z-1237-2022
Triathlon Tritanium Tibial Component (Size 6)
- FDA Device
- Class II
- ongoing
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of Triathlon Tritanium Tibial Component (Size 6) by Howmedica Osteonics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1237-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-30 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Howmedica Osteonics |
| Distribution | US |
Product
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
Reason
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.
Identifiers
| code_info | Catalog Number UDI-DI (GTIN) Lots 5536-B-600 07613327041514 CTD69463 5536-B-500 07613327041507 CTD69106 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1237-2022%22
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