FDA Device recall Z-2250-2021
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00
- FDA Device
- Class II
- completed
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00 by Exactech, citing 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).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2250-2021 |
| Classification | Class II |
| Status | completed |
| Initiated | 2021-06-29 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Exactech |
| Distribution | US |
Product
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Reason
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).
Identifiers
| code_info | Serial Numbers: 6465589-6465618; 6465641 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2250-2021%22
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