MONOCRYL Y315HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031058729), received between Feb 15, 2019 and Sep 10, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. May 10, 2024Open, Classified

   Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

   Z-2148-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER IS REPORTING THAT 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. CUSTOMER WILL RETURN THE REMAINING PACKS FROM THE SAME LOT FOR ANALYSIS. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185698 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HERNIA PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MANY TIMES. THE PRODUCT WAS DISCARDED DUE TO THE PATIENT HAVING AN INFECTION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085026 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HERNIA PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MANY TIMES. THE PRODUCT WAS DISCARDED DUE TO THE PATIENT HAVING AN INFECTION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085024 ↗
• MalfunctionApr 22, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE DETACHED FROM SUTURE AT SWAGE AFTER 7 PASSES, DURING SKIN CLOSURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187094 ↗
• MalfunctionFeb 18, 2021Break; Break

  IT WAS REPORTED BY VET THAT THE ANIMAL UNDERWENT AN ANIMAL PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. DURING USE OR TYING A KNOT, THE SUTURE WAS BREAKING TOO EASILY WHEN THE APPROPRIATE AMOUNT OF PRESSURE ON THE SUTURE MATERIAL WAS PLACED. ANOTHER TYPE OF SUTURE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345043 ↗
• MalfunctionFeb 18, 2021Break; Break

  IT WAS REPORTED BY VET THAT THE ANIMAL UNDERWENT AN ANIMAL PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. DURING USE OR TYING A KNOT, THE SUTURE WAS BREAKING TOO EASILY WHEN THE APPROPRIATE AMOUNT OF PRESSURE ON THE SUTURE MATERIAL WAS PLACED. ANOTHER TYPE OF SUTURE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345032 ↗
• MalfunctionApr 29, 2020Material Separation; Material Separation

  IT WAS REPORTED BY VET THAT AN ANIMAL UNDERWENT AN ORAL ANIMAL SURGERY IN 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. IT WAS ALSO REPORTED THAT THE NEEDLE WAS RETRIEVED AND ACCOUNTED PRIOR TO FINISHING THE SURGICAL PROCEDURE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10011795 ↗
• MalfunctionApr 29, 2020Material Separation; Material Separation

  IT WAS REPORTED BY VET THAT AN ANIMAL UNDERWENT AN ORAL ANIMAL SURGERY IN 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. IT WAS ALSO REPORTED THAT THE NEEDLE WAS RETRIEVED AND ACCOUNTED PRIOR TO FINISHING THE SURGICAL PROCEDURE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10011789 ↗
• MalfunctionApr 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN ORAL SURGERY IN 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF SUTURE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO PATIENT CONSEQUENCES. IT WAS ALSO REPORTED THAT THE NEEDLE REMOVED FROM THE PATIENT BUT NO RADIOGRAPHS WERE TAKEN AS IT WAS ORAL SURGERY AND THE NEEDLE WAS LOCATED VISUALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9953727 ↗
• MalfunctionApr 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN ORAL SURGERY IN 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF SUTURE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO PATIENT CONSEQUENCES. IT WAS ALSO REPORTED THAT THE NEEDLE REMOVED FROM THE PATIENT BUT NO RADIOGRAPHS WERE TAKEN AS IT WAS ORAL SURGERY AND THE NEEDLE WAS LOCATED VISUALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9953723 ↗
• MalfunctionFeb 15, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL SURGERY PROCEDURE ON (B)(6) 2019 AND A SUTURE WAS USED. DURING SURGERY, THE NEEDLE SEPARATED FROM THE SUTURE AS THE DOCTOR WAS APPLYING THE NEEDLE TO SUBCUTANEOUS TISSUE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8344904 ↗

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-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.