Compress Face Reamer Product Usage: Correction of revision of… — Class II medical device recall Z-0021-2015
Terminated recall by Biomet, Inc., reported 2014-10-15. Investigation determined that units supplied were missing the 4x21 degree helix angle.
| Recall number | Z-0021-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-09-17 |
| Classified | 2014-10-06 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2015-07-14 |
| Countries outside the US | NL |
| Quantity | 4 |
| Lot numbers | 615860, 765230 |
| Model numbers | 32-481000, 32-481001 |
Product
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Reason for recall
Investigation determined that units supplied were missing the 4x21 degree helix angle.
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-0021-2015. 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.