Coated VICRYL J261HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031038356), received between Sep 17, 2021 and Jul 30, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. One to two months later the patient experienced a wound complication/infection. Product was not available for return and testing. Additional information was requested.

  Patient problems: Unspecified Infection

  MAUDE report 50089797 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. One to two months later the patient experienced a wound complication/infection. Product was not available for return and testing. Additional information was requested.

  Patient problems: Unspecified Infection

  MAUDE report 50089789 ↗
• MalfunctionJun 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE HAD COME OFF THE SUTURE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT HARM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19529166 ↗
• MalfunctionMar 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. THE SUTURE BROKE OFF WHILE PULLING AFTER THE FIRST PASS THROUGH. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18828053 ↗
• MalfunctionMar 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. THE SUTURE BROKE OFF WHILE PULLING AFTER THE FIRST PASS THROUGH. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18828052 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ELECTIVE THA PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. THE PATIENT EXPERIENCED POST-OP INFLAMMATION AT THE SUTURE SITE. THE PATIENT ALSO HAD WOUND DEHISCENCE 2-3 MONTHS POST OP AND HAS BEEN TREATED FOR DEEP JOINT INFECTION X2. THE SURGEON OPINED THAT DOUBT IF DEEP INFECTION RELATED TO SUTURE AS PATIENT HAS A HISTORY OF IDDM AND PREVIOUS JOINT SEPSIS ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Inflammation; Unspecified Infection; Wound Dehiscence

  MAUDE report 12489450 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ELECTIVE LEFT THA PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. THE PATIENT EXPERIENCED POST-OP INFLAMMATION AT THE SUTURE SITE. THE PATIENT PRESENTED WITH PAIN, ERYTHEMA AND SWELLING ALONG THE SUTURE LINE 8 MONTHS POST OP. THE PATIENT WAS PLACED ON ORAL ANTIBIOTICS WHEN INFLAMMATORY MARKERS WERE FOUND TO BE ELEVATED, ESR AND CRP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Inflammation; Pain; Swelling/ Edema

  MAUDE report 12489327 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ELECTIVE LEFT THA PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. THE PATIENT EXPERIENCED POST-OP INFLAMMATION AT THE SUTURE SITE. THE PATIENT PRESENTED WITH PAIN, ERYTHEMA AND SWELLING ALONG THE SUTURE LINE 8 MONTHS POST OP. THE PATIENT WAS PLACED ON ORAL ANTIBIOTICS WHEN INFLAMMATORY MARKERS WERE FOUND TO BE ELEVATED, ESR AND CRP. IT WAS ALSO REPORTED THAT THE PATIENT HAD TWO SUCH ERUPTIONS, 5 AND 8 MONTHS POST OP, AND BOTH HAVE RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Inflammation; Pain; Swelling/ Edema

  MAUDE report 12488669 ↗