BEUDAMED
    FDA Recall Terminated

    Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0 cc. Model # 03003-01 Periobase Biphasic: Periobase, Synthetic Biphasic Dental Bone Biphasic Granules, 0.5 cc. Model #03002-01: Periobone Biphasic, Synthetic HA/TCP Dental Bone Graft Biphasic Granules, 0.5 cc. Periophil Biphasic (synthetic grafting material) is intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. Cytophil, Inc., 2485 Corporate Circle, Suite 2, East Roy, WI 53120.

    Recall: Z-1012-2012 · Initiated January 11, 2012

    Recall

    Recall Number
    Z-1012-2012
    Event Number
    61044
    Firm
    Cytophil, Inc
    FEI Number
    3007225376
    Product Code
    LYC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 11, 2012
    Posted
    February 13, 2012
    Terminated
    May 1, 2012
    Address
    2485 Corporate Cir, Ste 2, East Troy, WI, 53120-2577

    Description

    Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0 cc. Model # 03003-01 Periobase Biphasic: Periobase, Synthetic Biphasic Dental Bone Biphasic Granules, 0.5 cc. Model #03002-01: Periobone Biphasic, Synthetic HA/TCP Dental Bone Graft Biphasic Granules, 0.5 cc. Periophil Biphasic (synthetic grafting material) is intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. Cytophil, Inc., 2485 Corporate Circle, Suite 2, East Roy, WI 53120.

    Reason

    Cytophil Corporation is recalling Periophil Biphasic Periophil Biphasic, Periobase Biphasic, and Periobone Biphasic because devices were inadvertently shipped after receiving an inadequate dose of radiation and this product may not be sterile.

    Action

    Consignees were sent an "Urgent Medical Device Recall" letter dated January 11, 2012 by Cytophil. The letter described the problem and the product involved in the recall. The firm advised consignees to immediately examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, they were requested to identify their customers and notify them at once of this product recall. For questions, call 262-642-2765.

    Distribution

    Nationwide Distribution - Including the states of WI, GA, IL, SC, MO, and TX.

    Quantity

    547