Recall Z-0446-06 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
Depuy Mitek, a Johnson & Johnson Co.
Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740
| Date | Jan 26, 2006 (initiated Oct 27, 2005) |
| Status | Terminated |
| Reason | The device may contain one strand of suture instead of two strands |
| Root cause | Other |
| Action | DePuy Mitek initiated the recall to domestic accounts by letter on 10/27/05 and to J & J Affiliates by email. |
| Quantity | 19 boxes (5 pieces each) |
| Distribution | CA, IA, FL, MI, MO, OR, TX Foreign:Australia, Brazil, Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041075 | FASTIN RC ANCHOR Depuy Mitek, A Johnson & Johnson Company, Nov 9, 2004 |