Monosof N-2547Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521076082), received between Feb 21, 2019 and Oct 21, 2025 — classified as 3 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A NERVE INJURY RIGHT HAND D2 AND D3, WHILE SUTURING AFTER A PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. ANOTHER SIX SUTURES WERE USED BUT HAD THE SAME ISSUE. 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 23352253 ↗
• MalfunctionFeb 21, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING THE FREE FLAP CLOSURE IN A PLASTIC SURGERY, THEY WERE USING FOUR SUTURES TO CREATE ANASTOMOSES BETWEEN THE VESSELS BUT SUTURE KEPT BREAKING AND THEY COULD NOT CREATE ANASTOMOSES. THEY USED A COMPETITOR PRODUCT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358466 ↗
• MalfunctionFeb 21, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING THE FREE FLAP CLOSURE IN A PLASTIC SURGERY, THEY WERE USING SUTURES TO CREATE ANASTOMOSES BETWEEN THE VESSELS BUT SUTURE KEPT BREAKING AND THEY COULD NOT CREATE ANASTOMOSES. THEY USED A DIFFERENT PRODUCT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358465 ↗

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