Recall Z-0021-2015 ยท HTO Reamer
Biomet, Inc.
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.
| Date | Oct 6, 2014 (initiated Sep 17, 2014) |
| Status | Terminated |
| Reason | Investigation determined that units supplied were missing the 4x21 degree helix angle. |
| Root cause | Process control |
| Action | On September 17, 2014, "URGENT MEDICAL DEVICE RECALL NOTICE" was sent to the consignee Biomet Global Supply Chain Center (GSCC) by email and FedEx. GSCC notified all of the customers within Europe, the Middle East, and Asia that received the affected product. The recall notification included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call (574) 372-1570. |
| Quantity | 4 |
| Distribution | International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.