Recall Z-1157-2010 ยท GDW Staple, Implantable
Covidien LP
Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures.
| Date | Mar 16, 2010 (initiated Feb 8, 2010) |
| Status | Terminated |
| Reason | Fixation device may fail to fire and staple. |
| Root cause | Process control |
| Action | Covidien notified accounts by "Urgent Medical Device Recall" letters dated 2/8/10. The letter identified the affected product and the reason for recall. Customers are to examine their inventory, and remove and return recalled lots. Customers are to follow the instructions provided in the letter to return the affected product. Questions should be directed to a Covidien Representative. On June 23, 2010, the firm issued a letter to expand the recall to include 5 additional lots. |
| Quantity | 5,638 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |