Monosof SN-5699GRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521079182), received between Sep 8, 2017 and Feb 4, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 16, 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.

• MalfunctionFeb 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUTURE FELL OFF FROM THE NEEDLE WHEN THE USER WAS LIFTING THE NEEDLE FROM THE TABLE. THE SUTURE WAS NOT PERFECTLY ALIGNED WITH THE HUB OF THE NEEDLE WHEN THE PACKET WAS OPENED. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260787 ↗
• MalfunctionFeb 4, 2026Detachment of Device or Device Component; Packaging Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUTURE FELL OFF FROM THE NEEDLE WHEN THE USER WAS LIFTING THE NEEDLE FROM THE TABLE. THE SUTURE WAS NOT PERFECTLY ALIGNED WITH THE HUB OF THE NEEDLE WHEN THE PACKET WAS OPENED. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256931 ↗
• InjuryApr 21, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A REPAIR OF HEEL LACERATION, THE NEEDLE BROKE AND DISENGAGED INTO CAVITY WHILE SUTURING A LACERATION ON THE PATIENT'S HEEL. THE BROKEN PIECE WAS NOT RECOVERED. SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES AND HOSPITALIZATION WAS EXTENDED. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14168109 ↗
• MalfunctionAug 5, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING OPEN FASCIOTOMY FOR DUPUYTREN, THERE WERE 2 NEEDLES IN THE PACKAGE - ONE WAS ATTACHED TO THE NYLON THREAD THE OTHER WAS NOT. A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8859898 ↗
• MalfunctionSep 8, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A PROCEDURE. THE NEEDLE DETACHED FROM THE SUTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6850979 ↗

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