Device 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.
Z-0021-2015
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 69280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-0021-2015
Official wording
Reason: Investigation determined that units supplied were missing the 4x21 degree helix angle.
Code information: Catalog numbers: 32-481000 Lot Numbers: 615860, 765230 Catalog Number: 32-481001 Lot Number Identification: 121450, 392410, 765250, 974290
Distribution pattern: International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia.
Derived failure modes
-
Unknown
Investigation determined that units supplied were missing the 4x21 degree helix angle.