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Gentrix® PSMT2020Recalls & reported problems

Acell, Inc. · Gentrix® Surgical Matrix Thick 20 x 20 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 00386190001547), received between Dec 5, 2019 and Dec 5, 2019 — 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

  • Seroma1

Recent adverse event reports

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

  • InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON 11/8/1209, ACELL, INC. WAS NOTIFIED BY A SURGEON THAT A PATIENT EXPERIENCED A SEROMA FOUR (4) MONTHS POST OPERATIVE VENTRAL HERNIA REPAIR WITH AN ACELL DEVICE PLACED AS AN ONLAY ON (B)(6) 2019. THE PATIENT EXPERIENCED A WOUND DEHISCIENCE AT REPAIR SITE ON (B)(6) 2019. THE WOUND WAS DRAINED AND DEBRIDED ON (B)(6) 2019, THE WOUND WAS CULTURED WITH NO INFECTION PRESENT.

    Patient problems: Seroma

    MAUDE report 9418117 ↗

Other Mesh, surgical devices

All Mesh, surgical devices →

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