Coated VICRYL J267HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031038394), received between Nov 19, 2019 and Feb 8, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. AS DOCTOR WAS SUTURING FASCIA, NOTED TIP OF NEEDLE BROKE OFF. THE SURGEON CONTINUED PROCEDURE WITH SAME SUTURE BUT DIFFERENT LOT NUMBER. THERE WERE NO PATIENT ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16329311 ↗
• MalfunctionFeb 8, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. AS DOCTOR WAS SUTURING FASCIA, NOTED TIP OF NEEDLE BROKE OFF. THE SURGEON CONTINUED PROCEDURE WITH SAME SUTURE BUT DIFFERENT LOT NUMBER. THERE WERE NO PATIENT ISSUES. I BELIEVE ONLY ONE OF THEM WAS INVOLVED IN THIS ISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16329309 ↗
• MalfunctionNov 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2021 AND SUTURE WAS USED. UPON THE CLOSING PROCESS OF THE SURGICAL INCISION, THE SUTURE BROKE. IT WAS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12797641 ↗
• MalfunctionOct 14, 2021Break

  DURING CLOSING PROCESS OF SURGICAL INCISION, SUTURE O VICRYL CP-1 BROKE.

  Patient problems: Insufficient Information

  MAUDE report 12631531 ↗
• MalfunctionJan 7, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NAIL PLACEMENT PROCEDURE IN (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE OFF AS THE ATTENDING WAS CLOSING THE INCISION. IMAGING TAKEN TO RETRIEVE LOOSE PIECE. RADIOLOGIST READ AND CONFIRMED NO PIECES LEFT IN THE PATIENT WITH THE ATTENDING SURGEON. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9558654 ↗
• MalfunctionNov 19, 2019Break

  0 VICRYL SUTURE BROKE OFF AS ATTENDING WAS CLOSING INCISION. IMAGING TAKEN TO RETRIEVE LOOSE PIECE. RADIOLOGIST READ AND CONFIRMED NO PIECES LEFT IN PT W/ATTENDING SURGEON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9340915 ↗