Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Numbe
FDA device recall Z-0446-06 · posted 2006-01-26 · Terminated
Recall details
- Recalling firm
- Depuy Mitek, a Johnson & Johnson Co.
- Reason for recall
- The device may contain one strand of suture instead of two strands
- Action taken
- DePuy Mitek initiated the recall to domestic accounts by letter on 10/27/05 and to J & J Affiliates by email.
- Root cause
- Other
- Status
- Terminated
- Product code
- MAI
- Quantity affected
- 19 boxes (5 pieces each)
- Distribution
- CA, IA, FL, MI, MO, OR, TX Foreign:Australia, Brazil, Sweden
- Date initiated
- 2005-10-27
- Date posted
- 2006-01-26
- Date terminated
- 2006-05-02
- 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 |
|---|---|---|
| FASTIN RC ANCHOR (K041075) | Depuy Mitek, A Johnson & Johnson Company | 2004-11-09 |