Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp… — Class II medical device recall Z-2130-2013
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2013-09-04, distributed nationwide. Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.
| Recall number | Z-2130-2013 |
|---|---|
| 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 | 2013-07-02 |
| Classified | 2013-08-29 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2016-04-27 |
| Distributed | Nationwide (US) |
| Quantity | 10,537 units |
| Reason classes | packaging, device malfunction |
| Model numbers | 6541-2-609 |
Product
Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.
Reason for recall
Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.
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-2130-2013. 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.