Monosof SN-750Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521080126), received between Apr 10, 2017 and Jul 2, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K900531); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CAESAREAN SURGERY, THE NEEDLE WAS SEPARATED FROM THE THREAD AND REMAINED IN THE PATIENT'S ABDOMINAL CAVITY. X-RAY WAS DONE FOR LOCALIZED THE NEEDLE AND IT COULD BE REMOVED.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8752999 ↗
• InjuryApr 10, 2017Break; Break

  ACCORDING TO THE REPORTER: DURING STITCHING, THE SUTURE BROKE. THERE WAS NOT MORE THAN ONE DEFECTIVE DEVICE INVOLVED. THE EVENT LED TO OR EXTENDED PATIENT HOSPITALIZATION BECAUSE ANOTHER PROCEDURE HAD TO BE PERFORMED. THERE WILL BE AN ADDITIONAL OPERATION PERFORMED TO CORRECT THE ISSUE. THERE WAS NO TISSUE LOSS OR DAMAGE. SURGICAL TIME WAS NOT EXTENDED. PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Code Available

  MAUDE report 6475181 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K900531. One submission often covers many models, so check the product and lot details in each record.

• Z-1174-2023 · Dec 2, 2022 · Open, Classified
  Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 10
• Z-1173-2023 · Dec 2, 2022 · Open, Classified
  Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX