Monosof SN-663GRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521079731), received between Jan 18, 2018 and Feb 3, 2026 — classified as 2 injuries, 4 malfunctions.

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

• MalfunctionFeb 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SUTURING, THE NEEDLE DETACHED FROM THE SUTURE AT THE LAST STITCH. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246328 ↗
• MalfunctionApr 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE STRAND. THE DETACHMENT OCCURRED AS THE SUTURE WAS LOADED ON THE NEEDLE HOLDER, CAUSING THE STRAND TO COME LOOSE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748494 ↗
• MalfunctionJun 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ANKLE LIGAMENT REPAIR PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD. TO RESOLVE THE ISSUE, ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19453807 ↗
• InjuryJan 8, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE AN ANKLE FRACTURE OPEN REDUCTION AND INTERNAL FIXATION PROCEDURE, THE PATIENT PRESENTED WITH WOUND DEHISCENCE WITH RETAINED HARDWARE. IT WAS NOTED THAT THREE SUTURING DEVICES WERE USED. WOUND VACUUM PLACEMENT WAS PERFORMED TO RESOLVE THE ISSUE.

  Patient problems: Wound Dehiscence

  MAUDE report 9567244 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER USING FOUR DIFFERENT SUTURES IN AN ANKLE OPEN REDUCTION INTERNAL FIXATION, THERE WERE WOUND DEHISCENCE WITH RETAINED HARDWARE OF THE DISTAL FEMUR, RIGHT ANKLE. AN ADDITIONAL OPERATION WAS PERFORMED TO CORRECT THE ISSUE.

  Patient problems: No Code Available; Post Operative Wound Infection

  MAUDE report 9538221 ↗
• MalfunctionJan 18, 2018Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE ARE BREAKING APART AND COULD NOT BE USED. THEY ARE VERY WEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7203887 ↗

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