MONOCRYL Y333HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031058798), received between Jun 19, 2019 and Dec 5, 2024 — classified as 5 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K960653); 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT TWO NEEDLES BROKE OFF INTO THE PATIENT. THIS HAPPENED ON (B)(6) 2024 UNSURE WHEN IT ACTUALLY HAPPENED 2 DIFFERENT INCIDENTS WHERE THE NEEDLE BROKE OFF INTO PATIENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20856103 ↗
• MalfunctionJul 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE TIP PULLED OFF FROM THE SUTURE AND GOT STUCK IN THE PATIENT. THEY WERE ABLE TO RETRIEVE THE NEEDLE AND COMPLETE THE REST OF THE CASE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819182 ↗
• MalfunctionJun 22, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HYSTERECTOMY PROCEDURE ON 04/20/2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE NEEDLE WAS DETACHED FROM THE SUTURE FROM THE BEGINNING. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. UPON VISUAL ASSESSMENT OF THE RETURNED DETACHED NEEDLE, THE SWAGE AND ATTACHMENT AREA WAS NOTED TO BE AS EXPECTED. THE BARREL HOLE OF THE NEEDLE WAS EXAMINED UNDER MAGNIFICATION AND REMNANT SUTURE WAS OBSERVED. THE SUTURE COULD NOT BE DISPENSED SINCE HAVE BEGUN WITH THE PROCESS OF DEGRADATION. THIS CONDITION CAUSED THE NEEDLE TO BE DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17180967 ↗
• MalfunctionApr 16, 2021Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE BROKE AND THE SUTURE WAS NOT SWEDGED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11676496 ↗
• MalfunctionJun 19, 2019Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE BEFORE USE AND THE DEVICE WAS NOT USED ON THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. UPON EVALUATION OF THE DEVICE, THE SUTURE COULD NOT BE DISPENSED SINCE IT HAS BEGUN WITH THE PROCESS OF DEGRADATION AND THIS CAUSED THAT THE NEEDLE WAS NOT ATTACHED TO THE SUTURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712006 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960653. One submission often covers many models, so check the product and lot details in each record.

• 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
• Z-1311-2009 · Feb 2, 2009 · Terminated
  MONOCRYL (poliglecaprone 25 ) Suture, Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and/or ligation.