Exactech BIOLOX delta Femoral Head — Class II medical device recall Z-2251-2021
Completed recall by Exactech, Inc., reported 2021-08-18, distributed nationwide. Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36
| Recall number | Z-2251-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2021-06-29 |
| Classified | 2021-08-12 |
| Reported by FDA | 2021-08-18 |
| Distributed | Nationwide (US) |
| Quantity | 30 devices |
| Reason classes | labeling |
| Serial numbers | 6465619-6465640, 6465642-6465648 |
| Model numbers | 170-36-03 |
Product
Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
Reason for recall
Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
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-2251-2021. 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.