Coated VICRYL J762DRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031042810), received between Apr 22, 2019 and Oct 26, 2020 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Separation” (16 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ON (B)(6) 2020 AND SUTURE WAS USED. THE NEEDLE MADE ONE PASS INTO THE SKIN AND THE NEEDLE CAME OFF. THIS HAPPENED BEFORE THE SURGEON GAVE IT A GOOD PULL. THE NEEDLE WAS NOT WEDGED ON VERY GOOD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10732349 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ON (B)(6) 2020, AND SUTURE WAS USED. THE NEEDLE MADE ONE PASS INTO THE SKIN, AND THE NEEDLE CAME OFF. THIS HAPPENED BEFORE THE SURGEON GAVE IT A GOOD PULL. THE NEEDLE WAS NOT WEDGED ON VERY GOOD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10732348 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ON (B)(6) 2020, AND A SUTURE WAS USED. THE NEEDLE MADE ONE PASS INTO THE SKIN, AND THE NEEDLE CAME OFF. THIS HAPPENED BEFORE THE SURGEON GAVE IT A GOOD PULL. THE NEEDLE WAS NOT WEDGED ON VERY GOOD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10732347 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ON (B)(6) 2020, AND SUTURE WAS USED. THE NEEDLE MADE ONE PASS INTO THE SKIN AND THE NEEDLE CAME OFF. THIS HAPPENED BEFORE THE SURGEON GAVE IT A GOOD PULL. THE NEEDLE WAS NOT WEDGED ON VERY GOOD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10732328 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ON (B)(6) 2020, AND SUTURE WAS USED. THE NEEDLE MADE ONE PASS INTO THE SKIN AND THE NEEDLE CAME OFF. THIS HAPPENED BEFORE THE SURGEON GAVE IT A GOOD PULL. THE NEEDLE WAS NOT WEDGED ON VERY GOOD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10732327 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ON (B)(6) 2020 AND SUTURE WAS USED. THE NEEDLE MADE ONE PASS INTO THE SKIN AND THE NEEDLE CAME OFF. THIS HAPPENED BEFORE THE SURGEON GAVE IT A GOOD PULL. THE NEEDLE WAS NOT WEDGED ON VERY GOOD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10732326 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ON (B)(6) 2020 AND SUTURE WAS USED. THE NEEDLE MADE ONE PASS INTO THE SKIN AND THE NEEDLE CAME OFF. THIS HAPPENED BEFORE THE SURGEON GAVE IT A GOOD PULL. THE NEEDLE WAS NOT WEDGED ON VERY GOOD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10732325 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ON (B)(6) 2020, AND SUTURE WAS USED. THE NEEDLE MADE ONE PASS INTO THE SKIN AND THE NEEDLE CAME OFF. THIS HAPPENED BEFORE THE SURGEON GAVE IT A GOOD PULL. THE NEEDLE WAS NOT WEDGED ON VERY GOOD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10732324 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ON (B)(6) 2020 AND SUTURE WAS USED. THE NEEDLE MADE ONE PASS INTO THE SKIN AND THE NEEDLE CAME OFF. THIS HAPPENED BEFORE THE SURGEON GAVE IT A GOOD PULL. THE NEEDLE WAS NOT WEDGED ON VERY GOOD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10732323 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ON (B)(6) 2020, AND SUTURE WAS USED. THE NEEDLE MADE ONE PASS INTO THE SKIN AND THE NEEDLE CAME OFF. THIS HAPPENED BEFORE THE SURGEON GAVE IT A GOOD PULL. THE NEEDLE WAS NOT WEDGED ON VERY GOOD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10732321 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ON (B)(6) 2020, AND SUTURE WAS USED. THE NEEDLE MADE ONE PASS INTO THE SKIN, AND THE NEEDLE CAME OFF. THIS HAPPENED BEFORE THE SURGEON GAVE IT A GOOD PULL. THE NEEDLE WAS NOT WEDGED ON VERY GOOD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10732320 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ON (B)(6) 2020 AND SUTURE WAS USED. THE NEEDLE MADE ONE PASS INTO THE SKIN AND THE NEEDLE CAME OFF. THIS HAPPENED BEFORE THE SURGEON GAVE IT A GOOD PULL. THE NEEDLE WAS NOT WEDGED ON VERY GOOD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10732319 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ON (B)(6) 2020 AND SUTURE WAS USED. THE NEEDLE MADE ONE PASS INTO THE SKIN AND THE NEEDLE CAME OFF. THIS HAPPENED BEFORE THE SURGEON GAVE IT A GOOD PULL. THE NEEDLE WAS NOT WEDGED ON VERY GOOD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10732318 ↗
• MalfunctionOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ON (B)(6) 2020 AND SUTURE WAS USED. THE NEEDLE MADE ONE PASS INTO THE SKIN AND THE NEEDLE CAME OFF. THIS HAPPENED BEFORE THE SURGEON GAVE IT A GOOD PULL. THE NEEDLE WAS NOT WEDGED ON VERY GOOD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10732317 ↗
• MalfunctionSep 29, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE SUTURE WHILE MAKING ONE PASS INTO THE SKIN BEFORE THE SURGEON GAVE IT A GOOD PULL. THE NEEDLE WAS NOT WEDGED ON VERY GOOD. IT WAS A CONTROL RELEASE NEEDLE THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10599379 ↗
• MalfunctionSep 29, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE SUTURE WHILE MAKING ONE PASS INTO THE SKIN BEFORE THE SURGEON GAVE IT A GOOD PULL. THE NEEDLE WAS NOT WEDGED ON VERY GOOD. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10599377 ↗
• MalfunctionApr 22, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN NEUROLOGY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE OFF, TOWARDS THE VERY END OF THE PROCEDURE. THEY IRRIGATED FOR THE TIP AND FOUND THE TIP. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8536302 ↗