BEUDAMED
    FDA Recall Terminated

    MatriStem Plastic Surgery Matrix XS Intended for implantation to reinforce tissue where weakness exists in urological, gynecological, and gastrointestinal anatomy, including, but not limited to the following procedures: pubourethral support, tissue repair, body wall repair, and esophageal repair

    Recall: Z-2855-2011 · Initiated July 7, 2011

    Recall

    Recall Number
    Z-2855-2011
    Event Number
    59291
    Firm
    ACell, Inc
    FEI Number
    3005920706
    Product Code
    FTM
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 7, 2011
    Posted
    July 21, 2011
    Terminated
    October 21, 2011
    Address
    8671 Robert Fulton Drive, Suite B, Columbia, MD, 21046-2582

    Description

    MatriStem Plastic Surgery Matrix XS Intended for implantation to reinforce tissue where weakness exists in urological, gynecological, and gastrointestinal anatomy, including, but not limited to the following procedures: pubourethral support, tissue repair, body wall repair, and esophageal repair

    Reason

    Surgical mesh for implantation may have elevated endotoxin levels.

    Action

    ACELL, Inc. sent an "Urgent: Medical Device Safety Alert" letter dated July 07, 2011 to all affected customers. The letter notified customers (physicians) of the possibility of elevated endotoxin levels in the product and affected lots. They were instructed to monitor their patients receiving the affected implants. For additional information please contact the Director of Regulatory Affairs & Quality Assurance at (410) 953-8508.

    Distribution

    Nationwide (USA) Distribution including the states of CA, CT, FL, ID, IL, MD, MI, MS, NC, NJ, NV, NY, OH, OR, PA, TX and VA

    Quantity

    30 units