Monosof N-2546Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521076075), received between Jul 26, 2018 and Oct 26, 2022 — 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.

• MalfunctionOct 26, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, MULTIPLE STRANDS OF DEVICE BROKE DURING CLOSURE, THE SUTURE BROKE NEAR THE MIDDLE OF THE THREAD. IT DID NOT BREAK NEAR THE SWAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15674357 ↗
• MalfunctionSep 8, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE THREAD WAS BREAKING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382311 ↗
• MalfunctionJul 26, 2018Break

  ACCORDING TO THE REPORTER, WHEN RUNNING MICRO VASCULAR ANASTOMOSIS ON AN OPEN FREE FLAP PROCEDURE, NINE DIFFERENT SUTURE STRANDS BROKE ON THE FIRST PASS. THEY KEPT ON OPENING UP SUTURES UNTIL ONE DID NOT BREAK TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7722633 ↗

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