Monosof SN-671Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521079908), received between Feb 10, 2020 and Aug 7, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT DURING THE CLOSURE STEP OF A LEFT FOOT BONE BIOPSY OPEN PROCEDURE; THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738945 ↗
• MalfunctionJul 15, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST OPERATIVELY, NINE DAYS AFTER A VETERINARY SPAY PROCEDURE, THE PATIENT DEVELOPED A REACTION. A CUTANEOUS NODULES DEVELOPED WHERE THE SUTURES WERE PLACED.

  Patient problems: Nodule

  MAUDE report 19739889 ↗
• MalfunctionJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, NINE DAYS AFTER A VETERINARY SPAY PROCEDURE, CUTANEOUS NODULES DEVELOPED WHERE THE SUTURES WERE PLACED.

  Patient problems: Nodule

  MAUDE report 19739797 ↗
• MalfunctionMar 15, 2023Break; Break

  ACCORDING TO THE REPORTER, AT THE END OF THE PROCEDURE, THE THREAD OF THE DEVICE BROKE. AN ADDITIONAL SUTURE OF THE SAME TYPE AND LOT NUMBER WAS USED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16548201 ↗
• MalfunctionMar 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SKIN CLOSURE OF AN OPEN SPINE PROCEDURE, ABOUT 5 HOURS AFTER THE SURGERY, TWO NYLON NEEDLES POPPED OFF TWO TIMES. ANOTHER STITCH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9803989 ↗
• MalfunctionFeb 10, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN SPINE SURGERY, UPON PLACING THE DRAIN, THE DEVICE STRAND BROKE WHEN TYING. ANOTHER STITCH WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9687876 ↗

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