Recall Z-0989-2020 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Ethicon, Inc.
Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
| Date | Feb 4, 2020 (initiated Jan 3, 2020) |
| Status | Terminated |
| Reason | Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point. |
| Root cause | Process control |
| Action | The firm notified customers of the recall on January 3, 2020. Customers were informed to immediately cease usage or distribution of the recalled lot. All unused product subject to the recall is to be returned to the firm. If any recalled product was forwarded to another facility, contact that facility to arrange return. Customers were also asked to complete and return the included business reply form to the recalling firm even if they did not have product subject to this recall. In addition, customers are to keep the recall notice visibly posted for awareness until all product subject to this |
| Quantity | 23688 units |
| Distribution | Domestic distribution nationwide. US and Puerto Rico only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022269 | COATED VICRYL* (POLYGLACTIN 910) SUTURE ETHICON, Inc., Sep 13, 2002 |