Recall Z-1697-2024 ยท GAP Suture, Nonabsorbable, Silk
Covidien, LP
Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation.
| Date | Apr 29, 2024 (initiated Jan 25, 2024) |
| Status | Open, Classified |
| Reason | One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery. |
| Root cause | Process control |
| Action | On January 25, 2024, Medtronic issued an expansion to their earlier recall for sutures (RES 93768) concerning gamma sterilization. As part of that expansion, there was an additional lot of product which was exposed to more than the approved number of EO sterilization cycles, which is covered in this recall, RES 94351. The issue was communicated to affected consignees via letters. Consignees are asked to return any affected product they may have, forward this notification to those who need to be aware within the organization and to any location which the devices have been transferred. |
| Quantity | 36 total, OUS distribution only |
| Distribution | International distribution in the countries of Portugal and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981128 | SOFSILK SUTURE United States Surgical, A Division of Tyco Healthc, May 11, 1998 |