Recall Z-0611-06 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
Depuy Mitek, a Johnson & Johnson Co.
Depuy Mitek Bioknotless Anchor with Panacryl Suture Ref No. 212729
| Date | Mar 15, 2006 (initiated Feb 17, 2006) |
| Status | Terminated |
| Reason | The inserter shafts bend, as they were manufactured with a different stainless steel than specified. |
| Root cause | Other |
| Action | Depuy Mitek notified consignees by letter dated 2/17/06 to request accounts return devices. |
| Quantity | 200 pieces |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002639 | BIOKNOTLESS ANCHOR Mitek Products, May 11, 2001 |