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MONOCRYL D8901Recalls & reported problems

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

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031031487), received between Sep 7, 2022 and Sep 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (1 report).

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

  • Component Misassembled1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 7, 2022Component Misassembled; Component Misassembled

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED 12 MONOCRYL WERE SUPPOSED TO BE IN THE PACKAGING, BUT 8 MONOCRYL AND ALSO 4 VICRYL OF SUTURES WITHOUT NEEDLES WERE FOUND INSTEAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15369060 ↗

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.