Prosthesis — Class II medical device recall Z-1186-2021
Terminated recall by Howmedica Osteonics Corp., reported 2021-03-17, distributed in AZ, GA, MA, MI, MN, NH, NJ, OR…. Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size
| Recall number | Z-1186-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2021-02-10 |
| Classified | 2021-03-08 |
| Reported by FDA | 2021-03-17 |
| Terminated | 2023-05-30 |
| Distributed | AZ, GA, MA, MI, MN, NH, NJ, OR, PA, SC, UT, WA, WV |
| Quantity | 11 devices |
| Lot numbers | CTD44301 |
| Model numbers | 5536-B-400 |
Product
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Reason for recall
Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate.
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-1186-2021. 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.