BEUDAMED
    FDA Recall Terminated

    Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile

    Recall: Z-0476-06 · Initiated January 26, 2006

    Recall

    Recall Number
    Z-0476-06
    Event Number
    34506
    Firm
    QLT USA, Inc.
    FEI Number
    3001237858
    Product Code
    LYC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 26, 2006
    Posted
    February 4, 2006
    Terminated
    April 27, 2006
    Address
    701 Centre Avenue Fort, Collins, CO, 80526-1843

    Description

    Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile

    Reason

    Injectable needles were included in procedure kits instead of sterile blunt cannulas.

    Action

    Consignee was notified by letter on 1/26/2006.

    Distribution

    PA

    Quantity

    136 / 3 pack units