SynMesh 397.091Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034778532), received between Oct 6, 2023 and Apr 27, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Mechanical Problem

  MESH CUTTER SPRING BROKE WITHOUT BEING FORCED. THERE WAS NO DAMAGE OR INJURY REPORTED BY THE PATIENT OR USER. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25005564 ↗
• MalfunctionOct 6, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT WAS FOUND TO BE DAMAGED. THIS WAS IDENTIFIED BY THE LOAN KIT TECHNICIAN UPON LOAN KIT INSPECTION. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE SYNMESH® CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886149 ↗