Recall Z-1087-06 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Ethicon, Inc.
Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lactide.
| Date | Jun 2, 2006 (initiated May 4, 2006) |
| Status | Terminated |
| Reason | Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures. |
| Root cause | Other |
| Action | The firm sent out recall notification on 5/4/2006. The US consignees were sent a letter via return receipt. |
| Quantity | 1157 dozens |
| Distribution | Nationwide, Japan, Canada, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022269 | COATED VICRYL* (POLYGLACTIN 910) SUTURE ETHICON, Inc., Sep 13, 2002 |