Monosof SN-5667GRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521078802), received between Feb 13, 2018 and Aug 6, 2019 — classified as 5 malfunctions.

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

• MalfunctionAug 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN PROCEDURE, WHILE CLOSING OF THE SKIN, THE NEEDLE POPPED OFF ON THE SINGLE STRAND SUTURE WHILE TRYING TO SUTURE AN INTERRUPTED STITCH. ANOTHER STRAND OF SAME LOT AND PRODUCT CODE WAS OPENED AND THE NEEDLE POPPED OFF THAT ONE AS WELL. A NEW SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8867662 ↗
• MalfunctionAug 1, 2019Loss of or Failure to Bond; Product Quality Problem; Loss of or Failure to Bond; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A FLEXOR TENDON REPAIR PROCEDURE, WHEN USING THE SUTURE FOR SKIN CLOSURE, IT WAS NOTED THAT THE SUTURE SEEMS TO RETAIN MEMORY. THE SKIN SUTURE LOOSENED WHILE THEY WERE PREPARING TO PLACE THE POST-OPERATIVE DRESSING. THE SUTURE WAS RETIGHTENED, BUT SEVERAL STITCHES WERE RE-LOOSENED.

  Patient problems: No Information

  MAUDE report 8853612 ↗
• MalfunctionSep 17, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, MULTIPLE STRANDS OF THE PRODUCT, ALL HAD TOO LOOSE OF AN ATTACHMENT. WHEN THEY PULLED ON THE NEEDLE, THE THREAD POPPED OFF. THEY DID NOT USE THIS PRODUCT AND AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7882673 ↗
• MalfunctionAug 27, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A DERMATOLOGY PROCEDURE ON EXCISION OF SKIN LESION, THE POINT OF THE NEEDLE BROKE. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7818751 ↗
• MalfunctionFeb 13, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE WAS RIPPED THREE TIMES WHILE THEY WERE USING IT. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7267246 ↗

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