Monosof N-2512Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521075931), received between Jun 30, 2020 and Dec 13, 2021 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN AMPUTATED FINGER REPLANTATION PROCEDURE, WHILE PERFORMING ANASTOMOSIS OF THE ARTERIES, NERVES, AND VEINS OF THE FINGERS, THE NEEDLE AND THE SUTURE BROKE ON SIX DEVICES. IT WAS NOTED THAT THE SUTURE WAS TOO BRITTLE. THIS RESULTED TO A LONGER SUTURE TIME, ANASTOMOSIS TIME WAS TOO LONG AS WELL AND DAMAGE TO THE PATIENT¿S BLOOD VESSELS AND EPINEURIUM WHICH REQUIRED STRENGTHENED PATIENT MONITORING AND POSTOPERATIVE CARE. THE SURGEON REPLACED THE SUTURES MULTIPLE TIMES TO COMPLETE THE SURGERY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12987696 ↗
• MalfunctionNov 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO SURGERY, BOTH NEEDLE AND THREAD WERE FOUND BROKEN JUST AFTER OPENING THE PACKAGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759214 ↗
• MalfunctionJun 30, 2020Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN CEREBRAL BYPASS PROCEDURE, THE SUTURE THREAD WAS TORN, IT WAS ALREADY NOTICEABLE IN THE COLOR BECAUSE THEY FOUND THAT THE THREAD WAS BRIGHTER THAN USUAL. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10211572 ↗

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