Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals — Class II medical device recall Z-0906-2015
Terminated recall by Exactech, Inc., reported 2015-01-14. Mislabeled
| Recall number | Z-0906-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2014-10-09 |
| Classified | 2015-01-05 |
| Reported by FDA | 2015-01-14 |
| Terminated | 2016-06-08 |
| Countries outside the US | AR, AT, AU, CN, CY, ES, FR, GR, IN, JP, LB, NL, TN |
| Quantity | 96 |
| Reason classes | labeling |
| Serial numbers | 2925147, 2925194, 2925246, 2925293 |
| Model numbers | 244-02-03, 244-03-0, 244-03-03 |
Product
Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants
Reason for recall
Mislabeled
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-0906-2015. 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.