Monosof N-2718KRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521076204), received between Feb 11, 2020 and Sep 15, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break; Detachment of Device or Device Component

  It was reported that during a surgical procedure, the sutures were easily ruptured during use, and there were instances where the needle lost attachment from the suture.

  Patient problems: Insufficient Information

  MAUDE report 50766519 ↗
• MalfunctionSep 15, 2026Break; Detachment of Device or Device Component

  It was reported that during a procedure, the sutures were easily ruptured during use. Multiple defective devices were used in the pr ocedure. There were instances where the needle lost attachment from the suture. As a result of the device issue, the surgical procedure was extended by approximately 15 minutes. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766501 ↗
• MalfunctionOct 25, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING CORNEAL TRANSPLANTATION, WHILE STITCHING THE NEW CORNEA IN PLACE USING THE DOUBLE THROW SUTURING T ECHNIQUE, THE THREAD BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 12690435 ↗
• MalfunctionJan 19, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A CORNEAL TRANSPLANT SURGERY, WHEN SUTURING THE CORNEAL PERFORATION, THE THREAD BROKE. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. THE INCISION WAS EXTENDED BY LESS THAN 2.54 CM. THESE HAPPENED TO 3 DEVICES. NEW SUTURES WERE OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11193975 ↗
• MalfunctionFeb 11, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN EYE SURGERY, THE THREAD BROKE OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9693667 ↗

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