Z-1697-2024Class II

Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture...

Name: Z-1697-2024 Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture...
Creator: Covidien, LP
Published: 2024-01-25
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-01-25 / Open, Classified / root cause: manufacturing process

FDA source

Covidien, LP began a recall of Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft... on 2024-01-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1697-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-25
Posted: 2024-04-29
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: GAP Suture, Nonabsorbable, Silk
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 36 total, OUS distribution only
Distribution: International distribution in the countries of Portugal and Italy.
Product codes and lots: UDI-DI 20884521086422 Lot D2F2101RY

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1697-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1697-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-04-29

Product code GAP

K981128Class IISofsilk SutureUnited States Surgical, A Division of Tyco Healthc / cleared 1998-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)