VICRYL VKMMRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031056923), received between Dec 6, 2022 and Jun 12, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ILIAC CREST FREE FLAP SURGERY-RIGHT SIDE ON (B)(6) 2018 AND MESH WAS USED. THE SURGERY WAS DUE TO CANCER IN THE MANDIBLE AND A CRAFT FROM THE HIP WAS NEEDED TO REPLACE THE MANDIBLE. EXPLANTED DUE TO INFECTION. NEEDED 2ND SURGERY TO REMOVE MESH AND DRAIN INFECTION. THERE WAS PUSS AND MRSA WAS IDENTIFIED. PROLONGED HOSPITAL STAY FOR WEEKS AND POSSIBLE INCISIONAL HERNIA THAT HAS NOT BEEN FOLLOWED UP. SEVERE PAIN, DIFFICULTIES WALKING, UNSTABLE GAIT. PAIN IS GETTING WORSE AND NO FOLLOW-UP WITH POSSIBLE INCISIONAL HERNIA OCCURRED. THE PATIENT IS VERY STRESSED ABOUT THE DETERIORATION OF MOBILITY AND INCREASED PAIN. NO ADDITIONAL INFORMATION COULD BE REQUESTED DUE TO CONFIDENTIALITY.

  Patient problems: Ambulation or Postural Difficulties; Hernia; Loss of Range of Motion; Pain; Unspecified Infection

  MAUDE report 22197192 ↗
• MalfunctionMar 13, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND MESH WAS USED. THE INTERNAL PACKAGE OF THE MESH WAS BROKEN. THIS OCCURRED IN THE OPERATING ROOM WHEN THE SURGEON ASKED FOR THE MESH, RIGHT BEFORE OPENING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529421 ↗
• MalfunctionDec 6, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2022 AND MESH WAS USED. THE MESH WAS FOUND TO BE TORN INTO PIECES WHEN OPENED FOR USE. THE MESH WAS NOT USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923921 ↗