Coated VICRYL J443HRecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10705031039957), received between Apr 25, 2019 and Apr 15, 2026 — classified as 49 malfunctions.

The most frequently reported specific device problem is “Material Separation” (45 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BREAKS AS SOON AS IT IS PULLED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889456 ↗
• MalfunctionFeb 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THESE ITEMS WERE ALL RETURNED DUE TO DEFECTIVE WITH THE CUSTOMER REPORTING NEEDLE COMING OFF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307621 ↗
• MalfunctionFeb 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THESE ITEMS WERE ALL RETURNED DUE TO DEFECTIVE WITH THE CUSTOMER REPORTING NEEDLE COMING OFF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307419 ↗
• MalfunctionJul 8, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE PACKAGING SEEMS TO HAVE PUNCTURES/HOLES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19693305 ↗
• MalfunctionFeb 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT ARTHROPLASTY ON UNKNOWN DATE AND SUTURE WAS USED. SURGEON USED SUTURE FROM NEW BOX THAT HAD THE NEEDLE FALL OFF , LOSING THE NEEDLE WITH FIRST STITCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808906 ↗
• MalfunctionFeb 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT ARTHROPLASTY ON UNKNOWN DATE AND SUTURE WAS USED. SURGEON USED SUTURE FROM NEW BOX THAT HAD THE NEEDLE FALL OFF, LOSING THE NEEDLE WITH FIRST STITCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808870 ↗
• MalfunctionFeb 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT ARTHROPLASTY ON UNKNOWN DATE AND SUTURE WAS USED. SURGEON USED SUTURE FROM NEW BOX THAT HAD THE NEEDLE FALL OFF , LOSING THE NEEDLE WITH FIRST STITCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808840 ↗
• MalfunctionFeb 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT ARTHROPLASTY ON UNKNOWN DATE AND SUTURE WAS USED. SURGEON USED SUTURE FROM NEW BOX THAT HAD THE NEEDLE FALL OFF , LOSING THE NEEDLE WITH FIRST STITCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808831 ↗
• MalfunctionNov 30, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN 2023 AND SUTURE WAS USED. CUSTOMER REPORTED THAT THE NEEDLE POPPED OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236055 ↗
• MalfunctionNov 30, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN 2023 AND SUTURE WAS USED. CUSTOMER REPORTED THAT THE NEEDLE POPPED OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236052 ↗
• MalfunctionNov 30, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN 2023 AND SUTURE WAS USED. CUSTOMER REPORTED THAT THE NEEDLE POPPED OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236050 ↗
• MalfunctionNov 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS POPPING OFF OF THE NEEDLE WHEN BEING USED. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18151112 ↗
• MalfunctionOct 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE KEPT POPPING OFF WHILE CLOSING WITHIN PROCEDURE. A NEW SUTURE WAS USED TO FINISH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851628 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER THE ACCOUNT CONTACT THAT THE NEEDLES POPPING OFF. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF IT THERE WERE ANY PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17781301 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER THE ACCOUNT CONTACT THAT THE NEEDLES POPPING OFF. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF IT THERE WERE ANY PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17781296 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER THE ACCOUNT CONTACT THAT THE NEEDLES POPPING OFF. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF IT THERE WERE ANY PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17781294 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER THE ACCOUNT CONTACT THAT THE NEEDLES POPPING OFF. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF IT THERE WERE ANY PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17781095 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER THE ACCOUNT CONTACT THAT THE NEEDLES POPPING OFF. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF IT THERE WERE ANY PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17781093 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER THE ACCOUNT CONTACT THAT THE NEEDLES POPPING OFF. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF IT THERE WERE ANY PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17781092 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER THE ACCOUNT CONTACT THAT THE NEEDLES POPPING OFF. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF IT THERE WERE ANY PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17781088 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER THE ACCOUNT CONTACT THAT THE NEEDLES POPPING OFF. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF IT THERE WERE ANY PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17780832 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER THE ACCOUNT CONTACT THAT THE NEEDLES POPPING OFF. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF IT THERE WERE ANY PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17780829 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER THE ACCOUNT CONTACT THAT THE NEEDLES POPPING OFF. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF IT THERE WERE ANY PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17780828 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER THE ACCOUNT CONTACT THAT THE NEEDLES POPPING OFF. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF IT THERE WERE ANY PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17780827 ↗
• MalfunctionSep 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE UNKNOWN PROCEDURE, THE SUTURE WAS USED BY A SURGEON AND IT HAPPENED WHERE IT POPPED OFF. ANOTHER LOT WAS ABLE TO PRODUCE SECOND FIELD. HAVING SEPARATION OF THE NEEDLE AND THE SUTURE IS THE ISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17759393 ↗