Depuy Mitek Bioknotless Anchor with Ethibond Suture Ref No. 212728
FDA device recall Z-0610-06 · posted 2006-03-15 · Terminated
Recall details
- Recalling firm
- Depuy Mitek, a Johnson & Johnson Co.
- Reason for recall
- The inserter shafts bend, as they were manufactured with a different stainless steel than specified.
- Action taken
- Depuy Mitek notified consignees by letter dated 2/17/06 to request accounts return devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- MAI
- Quantity affected
- 200 pieces
- Distribution
- Nationwide
- Date initiated
- 2006-02-17
- Date posted
- 2006-03-15
- Date terminated
- 2006-06-28
- Location
- Raynham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOKNOTLESS ANCHOR (K002639) | Mitek Products | 2001-05-11 |