Monosof N-2756KRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521076341), received between Jan 13, 2021 and Jun 10, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN CATARACT PROCEDURE, WHEN ON CLOSURE, WHILE USING RUNNING TECHNIQUE, THE STRAND APPEARED SMALLER IN DIAMETER AT ONE END AND THE THREAD BROKE AT THAT LOCATION. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19501566 ↗
• MalfunctionDec 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE DEVICE BROKE AND IS GENERALLY IN POOR QUALITY.

  Patient problems: Insufficient Information

  MAUDE report 18251396 ↗
• MalfunctionDec 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE DEVICE BROKE AND IS GENERALLY IN POOR QUALITY.

  Patient problems: Insufficient Information

  MAUDE report 18251367 ↗
• MalfunctionDec 1, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CATARACT PROCEDURE, WHILE ON CLOSURE, THE SUTURE THREAD BROKE. THE SURGEON FELT THE TENSILE STRENGTH WAS MUCH WEAKER WITH THIS LOT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18251048 ↗
• MalfunctionDec 15, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN EXTRACAPSULAR CATARACT EXTRACTION, THE TWO STRANDS OF THE SUTURE BROKE AT EACH KNOT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15990839 ↗
• MalfunctionDec 15, 2022Break; Break

  ACCORDING TO THE REPORTER, ON AN OPEN EXTRACAPSULAR CATARACT EXTRACTION PLUS INTRAOCULAR LENS IMPLANTATION IN LEFT EYE, THE THREAD BROKE. TWO THREADS WERE USED SINCE THE SUTURES BREAK AT EACH KNOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15990528 ↗
• MalfunctionNov 10, 2022Dull, Blunt; Detachment of Device or Device Component; Dull, Blunt; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, BEFORE USING OR WHILE AT THE MOMENT OF MAKING THE STITCH, THE 3 SUTURES WERE BROKEN. FOR THE SECOND DEVICE, THE THREAD AND NEEDLE WERE BROKEN, THE DOCTOR NOTED THAT AFTER 3 STITCHES, THE NEEDLE LOSSES CUTTING EDGE AND THE THREAD WAS BREAKABLE.

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

  MAUDE report 15775003 ↗
• MalfunctionApr 26, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A VITRECTOMY PAN-RETINAL PHOTOCOAGULATION ON THE RIGHT EYE, DURING CLOSURE, WHILE THE SURGEON WAS TYING THE SUTURE, TWO DEVICES HAD THEIR SUTURE BROKEN. A NEW SUTURE FROM THE SAME BATCH WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14214956 ↗
• MalfunctionMar 29, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPTHALMOLOGY PROCEDURE, WHILE TYING A KNOT, THE THREAD BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585490 ↗
• MalfunctionJan 13, 2021Break; Break

  ACCORDING TO THE REPORTER, ON A CORNEAL WOUND PROCEDURE, WHILE SUTURING THE EYE DURING CLOSURE, THE THREAD BROKE. THE ISSUE HAPPENED BETWEEN 3-4 SUTURES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167053 ↗

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