Recall Z-0316-2017 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Aesculap Implant Systems LLC
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
| Date | Aug 1, 2016 |
| Status | Terminated |
| Reason | There is a potential for the needle to detach from the suture thread during surgery. If the needle becomes detached the defective suture will need to be replaced causing the wound to be sutured a second time. |
| Root cause | Process control |
| Action | An Urgent Medical Device Recall Notification Letter was mailed to customers on August 11, 2016 asking them to remove and return the affected product immediately. |
| Quantity | 180 units |
| Distribution | Distributed in Arizona |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031286 | SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE Aesculap, Inc., May 29, 2003 |