Monosof SN-662GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521079670), received between Mar 30, 2023 and Oct 17, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionOct 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SUTURE EXPERIENCED NEEDLE DETACHMENT WHILE THE SURGEON WAS PREPARING TO TIE, PRIOR TO INSERTING THE STRAND INTO THE PATIENT. THE THREAD SEPARATED FROM THE NEEDLE WHILE IN THE SURGEON'S HANDS AFTER THE INCISION. THE ISSUE WAS RESOLVED BY USING ANOTHER SUTURE FROM A DIFFERENT COMPANY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321230 ↗
• MalfunctionMar 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING, THE THREAD AND THE NEEDLE DISCONNECTED. THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLE AND REMOVE THE STRING FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 16648860 ↗

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-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
• 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