Monosof SN-3695Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521077997), received between May 15, 2017 and Aug 27, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall 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.

Recalls naming this device

1. Dec 21, 2023Class IIOpen, Classified

   Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.

   Z-0845-2024 · Root cause: Process control · Recall details · FDA record ↗

2. Dec 2, 2022Class IIOpen, Classified

   Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

   Z-1174-2023 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SECOND STITCH ON THE EYELID ON AN OPEN EYE LID CORRECTION, THE NEEDLE BROKE AND FELL INTO THE CAVITY. THE BROKEN POINT WAS REMOVED FROM THE EYELID WITH A NEEDLE HOLDER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380884 ↗
• MalfunctionNov 2, 2017Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE WAS BREAKING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6995932 ↗
• InjuryMay 15, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER: DURING SKIN CLOSURE( OPEN PROCEDURE) , THE NEEDLE BROKE. THE NEEDLE FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED BY OPERATION. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE ON (B)(6) 2017. THE SURGICAL TIME WAS EXTENDED DUE TO THIS PROBLEM. NO INJURY TO PATIENT, PATIENT STATUS : ALIVE - NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient; Radiation Exposure, Unintended

  MAUDE report 6567623 ↗

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