MONOCRYL Y339HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031058859), received between Nov 12, 2018 and Jun 14, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT, IT WAS FOUND THAT SOMETHING LIKE OIL STAIN WAS ON NEXT TO THE BARCODE OF THE BOX. UPON EVALUATION OF THE RETURNED SAMPLE, IT WAS DETERMINED THAT ONE SIDE OF THE BOX WAS DIRTY OR STAINED. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THE CL FOREIGN MATTER WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH QUALITY SYSTEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14684868 ↗
• MalfunctionApr 14, 2021Tear, Rip or Hole in Device Packaging; Material Integrity Problem; Tear, Rip or Hole in Device Packaging; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OBGYN SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN A NURSE WAS OPENING THE PACKAGE, IT WAS FOUND THAT THE SUTURE HAD BEEN BROKEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON EVALUATION OF THE RETURNED DEVICE, THE FOIL WAS INSPECTED AND MULTIPLES HOLES IN THE CAVITY AND EXCESSIVE WRINKLES WERE NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665544 ↗
• MalfunctionDec 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE IMMEDIATELY. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10973516 ↗
• MalfunctionNov 12, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON 10/12/2018 AND A SUTURE WAS USED. DURING SURGERY, THE NEEDLE WAS DETACHED FROM THE SUTURE WHEN TRYING TO USE THE NEEDLE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8061299 ↗

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.