MONOCRYL Y922HRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031059856), received between Jul 30, 2018 and Nov 26, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A CAT UNDERWENT SPAY PROCEDURE ON AN ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE KEPT POPPING OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20777242 ↗
• MalfunctionOct 3, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BREAKING WHEN USING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17861789 ↗
• MalfunctionAug 10, 2023Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER STATED THAT THE SUTURE CASING IS DIFFERENT. THERE ARE TABS LOCATED ALL AROUND THE SUTURE CASE AND THE SUTURE IS NOT RELEASING. WHEN THE CUSTOMER PULLS THE SUTURE, IT BREAKS, SO THEY MUST OPEN ALL THE TABS TO RELEASE THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17499896 ↗
• MalfunctionAug 8, 2023Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLES KEEP FALLING OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484960 ↗
• MalfunctionAug 8, 2023Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLES KEEP FALLING OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484959 ↗
• MalfunctionApr 21, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR PULLED OUT THE SUTURE AND IT BROKE AND DISINTEGRATED IN HAND. UPON EVALUATION OF THE RETURNED DEVICE, THE STRAND HAD BEGUN A DEGRADATION PROCESS. NO ADDITIONAL INFORMATION WAS PROVIDED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16791535 ↗
• MalfunctionFeb 28, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE SNAPPED IN HALF. THE NEEDLE PIECE DID NOT FALL INTO THE ANIMAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453542 ↗
• MalfunctionMay 18, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN USING THE PRODUCT, THEY COULD NOT PULL OUT THE SUTURE WITHOUT IT BREAKING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429908 ↗
• MalfunctionJan 12, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN SURGERY ON (B)(6), 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE NEAR THE END WHERE THE SUTURE IS ATTACHED. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13238012 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE USER FACILITY THAT DURING AN UNKNOWN PROCEDURE, THE SUTURE WAS ONLY HALF THE LENGTH IT SHOULD HAVE BEEN WHEN REMOVED FROM THE SUTURE PACKAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868620 ↗
• MalfunctionJan 2, 2019Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OVARIOHYSTERECTOMY ANIMAL PROCEDURE ON (B)(6) 2018 AND A SUTURE WAS USED. THE SUTURE BROKE POST-OPERATIVELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8210201 ↗
• MalfunctionJan 2, 2019Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OVARIOHYSTERECTOMY ANIMAL PROCEDURE ON (B)(6) 2018 AND A SUTURE WAS USED. THE SUTURE BROKE POST-OPERATIVELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8209918 ↗
• MalfunctionJul 30, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2018 AND SUTURE AS USED. DURING THE PROCEDURE, THE NEEDLE SEPARATED FROM THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE ANIMAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7733285 ↗

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.