Coated VICRYL J268HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031038417), received between May 23, 2019 and May 21, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K022269); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SURGEON WAS CLOSING THE WOUND GRABBED THE POINT OF THE NEEDLE AND THE POINT BROKE OFF. TIP WAS NOT RECOVERED. SURGEON CONTINUED WITH THAT SUTURE AND THE NEEDLE BROKE IN HALF AFTER THE SECOND PASS. SECOND FRAGMENT WAS RECOVERED. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE WOUND CLOSURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. APPROXIMATELY FIVE MINUTES ADDED TO SURGERY TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063528 ↗
• MalfunctionNov 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON REPORTS THAT THE SUTURE IS ACTING LIKE A CONTROLLED RELEASE SUTURE ("POPPING OFF THE NEEDLE"). THEY HAVE OPENED 2 BOXES OF THE 6 AND THE SUTURES ARE ALL ACTING THE SAME. ALL THE SAME LOT CODE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749141 ↗
• MalfunctionNov 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON REPORTS THAT THE SUTURE IS ACTING LIKE A CONTROLLED RELEASE SUTURE ("POPPING OFF THE NEEDLE"). THEY HAVE OPENED 2 BOXES OF THE 6 AND THE SUTURES ARE ALL ACTING THE SAME. ALL THE SAME LOT CODE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15748659 ↗
• MalfunctionNov 22, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE AND THREAD BECAME SEPARATED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852120 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ONCE THE WOUND WAS STARTING TO HEAL, THE DOCTOR REPORTED BUILDUP OF FLUID AND NECESSARY WOUND WASH OUT BEING PERFORMED TO CLEAN AFFECTED AREA AND REAPPROXIMATE WOUND EDGES. SPECIFIC ISSUES, SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING WERE POSSIBLE BUT SPECIFICS WEREN'T REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available; Not Applicable; Swelling; Unspecified Infection

  MAUDE report 8638264 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269. One submission often covers many models, so check the product and lot details in each record.

• Z-2144-2024 · May 10, 2024 · Open, Classified
  VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and
• Z-0989-2020 · Jan 3, 2020 · Terminated
  Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Z-1087-06 · May 4, 2006 · Terminated
  Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gyc