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Gentrix® PSMT2025Recalls & reported problems

Acell, Inc. · Gentrix® Surgical Matrix Thick 20 x 25 cm · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00386190001554), received between Jan 5, 2021 and Jan 5, 2021 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Abscess1
  • Hernia1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON 12/10/2020, ACELL, INC. WAS NOTIFIED THAT A GENTRIX DEVICE WAS DEBRIDED DUE TO A HERNIA RECURRENCE AND ABSCESS. THE GENTRIX DEVICE WAS IMPLANTED ON (B)(4) 2020 DUE TO A VENTRAL HERNIA. THE GENTRIX WAS USED IN A ONLAY FASCIAL REPAIR WITHOUT A DRAIN. ON (B)(6) 2020, THE PATIENT WAS SHOWN TO HAVE HERNIA RECURRENCE AND FLUID BUILDING. THE SURGEON REOPERATED AND DEBRIDED AREA AROUND GENTRIX DEVICE. THE GENTRIX DEVICE WAS NOT EXPLANTED BUT DEBRIDED TO ALLOW FOR THE BRIDGING OF THE POSTERIOR FASCIA WITH ANOTHER MANUFACTURER'S DEVICE, PHASIX. THE GENTRIX DEVICE REMAINS IN PLACE AND IS FUNCTIONING AS INTENDED.

    Patient problems: Abscess; Hernia

    MAUDE report 11121188 ↗

Other Mesh, surgical, collagen, plastic and reconstructive surgery devices

All Mesh, surgical, collagen, plastic and reconstructive surgery devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.