BEUDAMED
    FDA Enforcement Class II Terminated

    Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

    Recall: Z-1032-2019 · Reported March 27, 2019

    Enforcement

    Recall Number
    Z-1032-2019
    Event ID
    82228
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ACell, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2019
    Initiation Date
    February 14, 2019
    Classification Date
    March 21, 2019
    Termination Date
    May 7, 2020
    Address
    6640 Eli Whitney Dr Ste 200, N/A, Columbia, MD, 21046-2626, United States

    Description

    Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

    Reason

    The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.

    Code Info

    SN KN000087

    Distribution

    US nationwide distribution in the state of CA.

    Quantity

    1