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MONOCRYL Y682HRecalls & reported problems

Ethicon, LLC · Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031059504), received between Feb 22, 2019 and Feb 22, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K964072); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Separation2

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 22, 2019Material Separation; Material Separation

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE OFF OF THE NEEDLE WHILE THE DOCTOR WAS CLOSING THE SKIN. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8363385 ↗
  • MalfunctionFeb 22, 2019Material Separation; Material Separation

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE OFF OF THE NEEDLE WHILE THE DOCTOR WAS CLOSING THE SKIN. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8363383 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964072. One submission often covers many models, so check the product and lot details in each record.

  • Z-0487-2025 · Oct 8, 2024 · Open, Classified
    MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and
  • Z-2148-2024 · May 10, 2024 · Open, Classified
    MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345

Other SUTURE, ABSORBABLE, SYNTHETIC devices

All SUTURE, ABSORBABLE, SYNTHETIC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.