Monosof SN-5667Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521078796), received between Dec 26, 2019 and Oct 15, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE WAS DAMAGED ON THE MIDDLE PART. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288088 ↗
• MalfunctionJun 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, JUST ON LOADING THE SUTURE, THE NEEDLE AND SUTURE MATERIAL BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467817 ↗
• MalfunctionJan 19, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON HAD THE SUTURE BREAK WHEN TRYING TO USE IT. OPENED ANOTHER PACK AND WHEN TAKING SUTURE OUT OF PACK IT BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544187 ↗
• InjuryOct 13, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN GENDER AFFIRMING BILATERAL MASTECTOMY WITH FREE NIPPLE GRAFT, WHILE SUTURING IN THE DRAIN, THE NEEDLE WAS PASSED THROUGH THE SKIN. AS THE USER WAS GRASPING THE NEEDLE TO PULL THRU, THE NEEDLE BROKE AND FLEW THROUGH THE AIR. THE SURGEON WAS UNABLE TO LOCATE THE NEEDLE. AN X-RAY WAS PERFORMED TO CONFIRM THE BROKEN NEEDLE WAS NOT IN THE PATIENT.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 15601498 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF AN OPEN OSTEOTOMY OF THE 1ST AND 5TH METATARSAL WHERE THE DEVICES WERE USED FOR CLOSING USING THE INTERRUPTED SUTURING TECHNIQUE, THE INCISION LINES WERE EXTREMELY INFLAMED. THE TISSUE WAS DAMAGED. ANTIBIOTICS WERE USED TO RESOLVE THE ISSUE.

  Patient problems: Skin Inflammation/ Irritation; Unspecified Tissue Injury

  MAUDE report 13261403 ↗
• MalfunctionDec 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CLOSURE OF SKIN IN A OPEN PROCEDURE, THE NEEDLE CAME OFF THE THREAD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9519350 ↗

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