Coated VICRYL J683GRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031042186), received between Jul 27, 2022 and Oct 14, 2024 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, HAD 9 BOXES TOTAL OF ITEM J683G FROM THE SAME LOT# UBMPDE WHERE ALL OF THE SUTURES HAVE BEEN BREAKING OFF OF THE NEEDLE ONCE THE NEEDLE WAS PULLED THROUGH PATIENTS SKIN. THE IMPACT HAS BEEN PROCEDURE DELAY AND HAVING TO USE AN ADDITIONAL 16G NEEDLE TO FEED THE SUTURE IN ORDER TO COMPLETE THE SUTURE LINE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20444904 ↗
• MalfunctionOct 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, HAD 9 BOXES TOTAL OF ITEM J683G FROM THE SAME LOT# UBMPDE WHERE ALL OF THE SUTURES HAVE BEEN BREAKING OFF OF THE NEEDLE ONCE THE NEEDLE WAS PULLED THROUGH PATIENTS SKIN. THE IMPACT HAS BEEN PROCEDURE DELAY AND HAVING TO USE AN ADDITIONAL 16G NEEDLE TO FEED THE SUTURE IN ORDER TO COMPLETE THE SUTURE LINE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20444900 ↗
• MalfunctionOct 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, HAD 9 BOXES TOTAL OF ITEM J683G FROM THE SAME LOT# UBMPDE WHERE ALL OF THE SUTURES HAVE BEEN BREAKING OFF OF THE NEEDLE ONCE THE NEEDLE WAS PULLED THROUGH PATIENTS SKIN. THE IMPACT HAS BEEN PROCEDURE DELAY AND HAVING TO USE AN ADDITIONAL 16G NEEDLE TO FEED THE SUTURE IN ORDER TO COMPLETE THE SUTURE LINE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20444433 ↗
• MalfunctionOct 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, HAD 9 BOXES TOTAL OF ITEM J683G FROM THE SAME LOT# UBMPDE WHERE ALL OF THE SUTURES HAVE BEEN BREAKING OFF OF THE NEEDLE ONCE THE NEEDLE WAS PULLED THROUGH PATIENTS SKIN. THE IMPACT HAS BEEN PROCEDURE DELAY AND HAVING TO USE AN ADDITIONAL 16G NEEDLE TO FEED THE SUTURE IN ORDER TO COMPLETE THE SUTURE LINE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20444263 ↗
• MalfunctionOct 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, HAD 9 BOXES TOTAL OF ITEM J683G FROM THE SAME LOT# UBMPDE WHERE ALL OF THE SUTURES HAVE BEEN BREAKING OFF OF THE NEEDLE ONCE THE NEEDLE WAS PULLED THROUGH PATIENTS SKIN. THE IMPACT HAS BEEN PROCEDURE DELAY AND HAVING TO USE AN ADDITIONAL 16G NEEDLE TO FEED THE SUTURE IN ORDER TO COMPLETE THE SUTURE LINE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440987 ↗
• MalfunctionOct 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, HAD 9 BOXES TOTAL OF ITEM J683G FROM THE SAME LOT# UBMPDE WHERE ALL OF THE SUTURES HAVE BEEN BREAKING OFF OF THE NEEDLE ONCE THE NEEDLE WAS PULLED THROUGH PATIENTS SKIN. THE IMPACT HAS BEEN PROCEDURE DELAY AND HAVING TO USE AN ADDITIONAL 16G NEEDLE TO FEED THE SUTURE IN ORDER TO COMPLETE THE SUTURE LINE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440448 ↗
• MalfunctionOct 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, HAD 9 BOXES TOTAL OF ITEM J683G FROM THE SAME LOT# UBMPDE WHERE ALL OF THE SUTURES HAVE BEEN BREAKING OFF OF THE NEEDLE ONCE THE NEEDLE WAS PULLED THROUGH PATIENTS SKIN. THE IMPACT HAS BEEN PROCEDURE DELAY AND HAVING TO USE AN ADDITIONAL 16G NEEDLE TO FEED THE SUTURE IN ORDER TO COMPLETE THE SUTURE LINE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440396 ↗
• MalfunctionOct 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, HAD 9 BOXES TOTAL OF ITEM J683G FROM THE SAME LOT# UBMPDE WHERE ALL OF THE SUTURES HAVE BEEN BREAKING OFF OF THE NEEDLE ONCE THE NEEDLE WAS PULLED THROUGH PATIENTS SKIN. THE IMPACT HAS BEEN PROCEDURE DELAY AND HAVING TO USE AN ADDITIONAL 16G NEEDLE TO FEED THE SUTURE IN ORDER TO COMPLETE THE SUTURE LINE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440252 ↗
• MalfunctionOct 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, HAD 9 BOXES TOTAL OF ITEM J683G FROM THE SAME LOT# UBMPDE WHERE ALL OF THE SUTURES HAVE BEEN BREAKING OFF OF THE NEEDLE ONCE THE NEEDLE WAS PULLED THROUGH PATIENTS SKIN. THE IMPACT HAS BEEN PROCEDURE DELAY AND HAVING TO USE AN ADDITIONAL 16G NEEDLE TO FEED THE SUTURE IN ORDER TO COMPLETE THE SUTURE LINE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440195 ↗
• MalfunctionAug 4, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF RECURRENT CARCINOMA FROM RIGHT MASTECTOMY SITE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE SUTURE BROKE WHILE IN USE. THE NEEDLE TIP WAS LOCATED AND REMOVED FROM THE WOUND. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15166735 ↗
• MalfunctionAug 4, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF RECURRENT CARCINOMA FROM RIGHT MASTECTOMY SITE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE SUTURE BROKE WHILE IN USE. THE NEEDLE TIP WAS LOCATED AND REMOVED FROM THE WOUND. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15166653 ↗
• MalfunctionJul 27, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, A TOTAL OF FOUR OF THE SUTURES WERE USED. TWO OF THE FOUR SUTURES NEEDLE TIPS BROKE OFF WHILE IN USE. THEY WERE ABLE TO BE RETRIEVED BY THE SURGEON. THEY WERE ALL FROM THE SAME SUTURE BOX. THE BROKEN SUTURE IS NOT AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114310 ↗
• MalfunctionJul 27, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, A TOTAL OF FOUR OF THE SUTURES WERE USED. TWO OF THE FOUR SUTURES NEEDLE TIPS BROKE OFF WHILE IN USE. THEY WERE ABLE TO BE RETRIEVED BY THE SURGEON. THEY WERE ALL FROM THE SAME SUTURE BOX. THE BROKEN SUTURE IS NOT AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114271 ↗
• MalfunctionJul 27, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, A TOTAL OF FOUR OF THE SUTURES WERE USED. TWO OF THE FOUR SUTURES NEEDLE TIPS BROKE OFF WHILE IN USE. THEY WERE ABLE TO BE RETRIEVED BY THE SURGEON. THEY WERE ALL FROM THE SAME SUTURE BOX. THE BROKEN SUTURE IS NOT AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114236 ↗