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MONOCRYL MCP340HRecalls & reported problems

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031046405), received between Jul 22, 2022 and Jul 22, 2022 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K050845, K201996); 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.

Recalls naming this device

  1. May 10, 2024Open, Classified

    Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

    Z-2149-2024 · Root cause: Under Investigation by firm · FDA record ↗

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.

  • MalfunctionJul 22, 2022Component Misassembled; Component Misassembled

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL SURGERY ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS TAKEN OUT OF THE BOX AND FOUND TO BE INCORRECT. THE CORRECT PRODUCT WAS SUPPOSED TO BE A DIFFERENT PRODUCT, AND THE BOX DID HAVE PROPER PACKAGING. THE SUTURE IN THE BOX WAS NOT CORRECT. THE PROCEDURE WAS COMPLETED WITH NO HARM. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15084950 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050845, K201996. One submission often covers many models, so check the product and lot details in each record.

  • Z-1312-2009 · Feb 2, 2009 · Terminated
    MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture; Ethicon, Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and/o

Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices

All SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices →

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