Monosof N-2543Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521076051), received between Feb 21, 2019 and Sep 29, 2026 — classified as 3 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 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.

• MalfunctionSep 29, 2026Break

  It was reported that during mammary anastomosis, while suturing, the suture broke in the middle.

  Patient problems: Insufficient Information

  MAUDE report 50935155 ↗
• MalfunctionMar 18, 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 ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8430116 ↗
• 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 8358169 ↗

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