Recall Z-0547-04 ยท FZP Clip, Implantable
Weck
Hem-o-LokSMX Legating Clip, REF 544220, Lot 988384, Non-absorbable Polymer Ligation Clips, Sterile EO, Weck Closure Systems, Research Triangle Park, NC 27709, Sterile, Single use, Disposable.
| Date | Feb 25, 2004 (initiated Jan 23, 2004) |
| Status | Terminated |
| Reason | Malformation of the Hem-o-lok SMX clip. |
| Root cause | Other |
| Action | Consignees were notified by letter via Federal Express (Domestic consignees), Email (International and Weck Sales Representatives), and Fax (Weck Sales Representatives) beginning 01/23/2004. |
| Quantity | 70 sales units |
| Distribution | Distributors and hospitals in AL, CA, FL, MA, MD, MI, NC, NY, OH, OR, PA, SC, TX, Korea and France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982941 | HEM-O-LOK MODEL NUMBERS 523900, 523970 Weck Closure Systems, Nov 19, 1998 |