Howmedica Osteonics Corp — Class II medical device recall Z-0964-2013
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2013-03-27, distributed in NJ. The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on t
| Recall number | Z-0964-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2013-01-24 |
| Classified | 2013-03-18 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2015-05-06 |
| Distributed | NJ |
| Lot numbers | AP5W52, AP7H19 |
| Model numbers | I-K2401KF00 |
Product
Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE
Reason for recall
The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed.
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-0964-2013. 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.