Monosof SN-5666Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521078765), received between Mar 31, 2017 and Jul 10, 2018 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2018Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SUTURE BROKE IN HALF WHILE TYING A KNOT. THEY OPENED A NEW SUTURE TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7673311 ↗
• InjuryApr 4, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER: THE DOCTOR REPORTED MULTIPLE PATIENTS RETURNING WITH REDNESS AND SWELLING AT THE SUTURE SITE. ALL OF THE PATIENTS HAD TO HAVE THE SUTURES REMOVED AND REPLACED. THERE WAS NO MEDICAL ATTENTION OR HOSPITALIZATION REQUIRED. THE WOUNDS HEALED SUCCESSFULLY.

  Patient problems: Local Reaction; Swelling

  MAUDE report 6456136 ↗
• InjuryApr 3, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER: THE DOCTOR REPORTED MULTIPLE PATIENTS RETURNING WITH REDNESS AND SWELLING AT THE SUTURE SITE. ALL OF THE PATIENTS HAD TO HAVE THE SUTURES REMOVED AND REPLACED. THERE WAS NO MEDICAL ATTENTION OR HOSPITALIZATION REQUIRED. THE WOUNDS HEALED SUCCESSFULLY.

  Patient problems: Local Reaction; Swelling

  MAUDE report 6453199 ↗
• InjuryApr 3, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER: THE DOCTOR REPORTED MULTIPLE PATIENTS RETURNING WITH REDNESS AND SWELLING AT THE SUTURE SITE. ALL OF THE PATIENTS HAD TO HAVE THE SUTURES REMOVED AND REPLACED. THERE WAS NO MEDICAL ATTENTION OR HOSPITALIZATION REQUIRED. THE WOUNDS HEALED SUCCESSFULLY.

  Patient problems: Local Reaction; Swelling

  MAUDE report 6453094 ↗
• InjuryApr 3, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  THERE WAS REDNESS AND SWELLING AT THE SUTURE SITE. THE SUTURE HAD TO BE REMOVED AND REPLACED. THERE WAS NO MEDICAL ATTENTION OR HOSPITALIZATION REQUIRED. THE WOUND HEALED SUCCESSFULLY.

  Patient problems: Local Reaction; Swelling

  MAUDE report 6453077 ↗
• InjuryApr 3, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER: THE DOCTOR REPORTED MULTIPLE PATIENTS RETURNING WITH REDNESS AND SWELLING AT THE SUTURE SITE. ALL OF THE PATIENTS HAD TO HAVE THE SUTURES REMOVED AND REPLACED. THERE WAS NO MEDICAL ATTENTION OR HOSPITALIZATION REQUIRED. THE WOUNDS HEALED SUCCESSFULLY.

  Patient problems: Local Reaction; Swelling

  MAUDE report 6453069 ↗
• InjuryApr 3, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  THE DOCTOR REPORTED MULTIPLE PATIENTS RETURNING WITH REDNESS AND SWELLING AT THE SUTURE SITE. ALL OF THE PATIENTS HAD TO HAVE THE SUTURES REMOVED AND REPLACED. THERE WAS NO MEDICAL ATTENTION OR HOSPITALIZATION REQUIRED. THE WOUNDS HEALED SUCCESSFULLY.

  Patient problems: Local Reaction; Swelling

  MAUDE report 6453058 ↗
• InjuryMar 31, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THERE WAS REDNESS AND SWELLING AT THE SUTURE SITE. THE SUTURE HAD TO BE REMOVED AND REPLACED. THERE WAS NO MEDICAL ATTENTION OR HOSPITALIZATION REQUIRED. THE WOUND HEALED SUCCESSFULLY.

  Patient problems: Local Reaction; Swelling

  MAUDE report 6450107 ↗
• InjuryMar 31, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THERE WAS REDNESS AND SWELLING AT THE SUTURE SITE. THE SUTURE HAD TO BE REMOVED AND REPLACED. THERE WAS NO MEDICAL ATTENTION OR HOSPITALIZATION REQUIRED. THE WOUND HEALED SUCCESSFULLY.

  Patient problems: Local Reaction; Swelling

  MAUDE report 6449452 ↗

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