Coated VICRYL J718TRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031042520), received between Mar 15, 2022 and Mar 15, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Separation” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) "222" AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE STRANDS OF SUTURE THE NEEDLE POPPED OFF PREMATURELY. NEEDLE WOULD BARELY MAKE IT THROUGH THE TISSUE BEFORE THE NEEDLE WOULD POP OFF. MULTIPLE LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE AS THE PREMATURE POP OFF CONTINUED TO HAPPEN THROUGHOUT THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770894 ↗
• MalfunctionMar 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) "222" AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE STRANDS OF SUTURE THE NEEDLE POPPED OFF PREMATURELY. NEEDLE WOULD BARELY MAKE IT THROUGH THE TISSUE BEFORE THE NEEDLE WOULD POP OFF. MULTIPLE LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE AS THE PREMATURE POP OFF CONTINUED TO HAPPEN THROUGHOUT THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770880 ↗
• MalfunctionMar 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) "222" AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE STRANDS OF SUTURE THE NEEDLE POPPED OFF PREMATURELY. NEEDLE WOULD BARELY MAKE IT THROUGH THE TISSUE BEFORE THE NEEDLE WOULD POP OFF. MULTIPLE LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE AS THE PREMATURE POP OFF CONTINUED TO HAPPEN THROUGHOUT THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770874 ↗
• MalfunctionMar 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE STRANDS OF SUTURE THE NEEDLE POPPED OFF PREMATURELY. NEEDLE WOULD BARELY MAKE IT THROUGH THE TISSUE BEFORE THE NEEDLE WOULD POP OFF. MULTIPLE LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE AS THE PREMATURE POP OFF CONTINUED TO HAPPEN THROUGHOUT THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770872 ↗
• MalfunctionMar 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE STRANDS OF SUTURE THE NEEDLE POPPED OFF PREMATURELY. NEEDLE WOULD BARELY MAKE IT THROUGH THE TISSUE BEFORE THE NEEDLE WOULD POP OFF. MULTIPLE LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE AS THE PREMATURE POP OFF CONTINUED TO HAPPEN THROUGHOUT THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770871 ↗
• MalfunctionMar 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE STRANDS OF SUTURE THE NEEDLE POPPED OFF PREMATURELY. NEEDLE WOULD BARELY MAKE IT THROUGH THE TISSUE BEFORE THE NEEDLE WOULD POP OFF. MULTIPLE LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE AS THE PREMATURE POP OFF CONTINUED TO HAPPEN THROUGHOUT THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770867 ↗
• MalfunctionMar 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE STRANDS OF SUTURE THE NEEDLE POPPED OFF PREMATURELY. NEEDLE WOULD BARELY MAKE IT THROUGH THE TISSUE BEFORE THE NEEDLE WOULD POP OFF. MULTIPLE LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE AS THE PREMATURE POP OFF CONTINUED TO HAPPEN THROUGHOUT THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770859 ↗
• MalfunctionMar 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE STRANDS OF SUTURE THE NEEDLE POPPED OFF PREMATURELY. NEEDLE WOULD BARELY MAKE IT THROUGH THE TISSUE BEFORE THE NEEDLE WOULD POP OFF. MULTIPLE LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE AS THE PREMATURE POP OFF CONTINUED TO HAPPEN THROUGHOUT THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770854 ↗
• MalfunctionMar 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE STRANDS OF SUTURE THE NEEDLE POPPED OFF PREMATURELY. NEEDLE WOULD BARELY MAKE IT THROUGH THE TISSUE BEFORE THE NEEDLE WOULD POP OFF. MULTIPLE LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE AS THE PREMATURE POP OFF CONTINUED TO HAPPEN THROUGHOUT THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770843 ↗
• MalfunctionMar 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE STRANDS OF SUTURE THE NEEDLE POPPED OFF PREMATURELY. NEEDLE WOULD BARELY MAKE IT THROUGH THE TISSUE BEFORE THE NEEDLE WOULD POP OFF. MULTIPLE LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE AS THE PREMATURE POP OFF CONTINUED TO HAPPEN THROUGHOUT THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770828 ↗
• MalfunctionMar 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE STRANDS OF SUTURE THE NEEDLE POPPED OFF PREMATURELY. NEEDLE WOULD BARELY MAKE IT THROUGH THE TISSUE BEFORE THE NEEDLE WOULD POP OFF. MULTIPLE LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE AS THE PREMATURE POP OFF CONTINUED TO HAPPEN THROUGHOUT THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770807 ↗
• MalfunctionMar 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) "222" AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE STRANDS OF SUTURE THE NEEDLE POPPED OFF PREMATURELY. NEEDLE WOULD BARELY MAKE IT THROUGH THE TISSUE BEFORE THE NEEDLE WOULD POP OFF. MULTIPLE LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE AS THE PREMATURE POP OFF CONTINUED TO HAPPEN THROUGHOUT THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770802 ↗