MONOCRYL Y762HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031059573), received between Jul 15, 2020 and Jan 14, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDEWENT A PYOMETRA RESOLUTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. PET HAD AN UNEVENTFUL RECOVERY AND WAS DISCHARGED. ON (B)(6) 2021, PATIENT PRESENTED WITH A COMPLETE DEHISCE OF THE ABDOMINAL CAVITY. THIS WAS ABOUT 3 WEEKS POST SURGERY WHEN THE ENTIRE INCISION HAD APPEARED TO BE HEALED. DURING THE HERNIA/DEHISCE SURGERY REPAIR THE SUTURE MATERIAL 2-0 MONOCRYL OF THE LINEA APPEARED TO BE BROKEN AND FRAYED APPROXIMATELY 1-2 CM FROM THE END KNOTS OF THE INCISION AND THERE WERE 1-3 CM PIECES THAT APPEARED TO HAVE FRAYED OR BROKEN ENDS. ALL THE KNOTS IN THE LINEA AND THE END KNOTS APPEARED TO BE INTACT. THE OWNER WAS QUESTIONED AND THE PET WAS STRICTLY INDOORS, DID NOT APPEAR TO HAVE HAD A TRAUMATIC EVENT AND HAD BEEN DOING FINE PRIOR TO A VISIBLE BULGE AT THE INCISION LINE. THE PET HAD A COMPLETE LOSS OF INCISION INTERGRITY WITH INTESTINES OUTSIDE THE ABDOMEN. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia; Wound Dehiscence

  MAUDE report 13261795 ↗
• MalfunctionAug 11, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL SURGERY ON (B)(6) 2021 AND THE SUTURE WAS USED. UPON EVALUATION, SHORT INSERTION WAS OBSERVED IN THE STRAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310009 ↗
• MalfunctionJul 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL SURGERY IN 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF OF THE SUTURE MID STITCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10276495 ↗
• MalfunctionJul 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL SURGERY IN 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF OF THE SUTURE MID STITCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10276493 ↗
• MalfunctionJul 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL SURGERY IN 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF OF THE SUTURE MID STITCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10276483 ↗
• MalfunctionJul 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL SURGERY IN 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF OF THE SUTURE MID STITCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10276481 ↗

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.