MONOCRYL Y942HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031059931), received between Jul 25, 2018 and Feb 27, 2019 — classified as 3 malfunctions.

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

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE EVERY TIME ANY TENSION WAS PUT ON IT. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8374529 ↗
• MalfunctionAug 13, 2018Break; Break

  IT WAS REPORTED THAT A CAT UNDERWENT AN OVARIECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING LINEA CLOSURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7777032 ↗
• MalfunctionJul 25, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN CANINE UNDERWENT AN OVARIECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DETACHED AT SWAGE AFTER ONE PASSAGE THROUGH TISSUE. HAD TO OPEN ANOTHER PACKET TO COMPLETE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7717659 ↗

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.