FDA Device recall Z-0021-2015
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor res…
- FDA Device
- Class II
- terminated
- Published 2014-10-15
On 2014-10-15 the FDA classified a Class II recall of Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor res… by Biomet, citing investigation determined that units supplied were missing the 4x21 degree helix angle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0021-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-17 |
| Published | 2014-10-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | n/a |
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
Investigation determined that units supplied were missing the 4x21 degree helix angle.
Identifiers
| code_info | Catalog numbers: 32-481000 Lot Numbers: 615860, 765230 Catalog Number: 32-481001 Lot Number Identification: 121450, 392410, 765250, 974290 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0021-2015%22
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