Z-0021-2015 Class II Terminated
FDA device recall Z-0021-2015 was initiated by Biomet, Inc. on Sep 17, 2014 and is designated Class II. Reason for recall: Investigation determined that units supplied were missing the 4x21 degree helix angle. The recall status is terminated (terminated Jul 14, 2015). Affected quantity: 4.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 15, 2014
- Initiation Date
- Sep 17, 2014
- Termination Date
- Jul 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4
Product Description
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.
Distribution Pattern
International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia.
Code Information
Catalog numbers: 32-481000 Lot Numbers: 615860, 765230 Catalog Number: 32-481001 Lot Number Identification: 121450, 392410, 765250, 974290
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0021-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026