Recall Z-0021-2015— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2014-09-17, terminated 2015-07-14. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-17
- Terminated
- 2015-07-14
- Firm location
- Warsaw, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.