BEUDAMED
    FDA Recall Terminated

    VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rectocele.

    Recall: Z-0807-2021 · Initiated December 11, 2020

    Recall

    Recall Number
    Z-0807-2021
    Event Number
    86930
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FTM
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 11, 2020
    Terminated
    March 24, 2023
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rectocele.

    Reason

    VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.

    Action

    An Urgent Medical Device Recall communication, FA-2020-057, will be sent to all affected customers via U.S.P.S., first class mail.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of FL, IL, MA, MS, OH, OR, TX, VA, WA, WV and the countries of Australia, Poland, and United Kingdom.

    Quantity

    192 units