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.
This recall is currently active, issued April 29, 2024.
- Recall Initiated
- January 25, 2024
- Posted
- April 29, 2024
- Recall Number
- Z-1697-2024
- Quantity
- 36 total, OUS distribution only
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
International distribution in the countries of Portugal and Italy.
Lot / Code Info
UDI-DI 20884521086422 Lot D2F2101RY
Root Cause
Process control
Action Taken
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.