BEUDAMED
    FDA Recall Terminated

    Sinu-Lift(TM) System, LLC., Model SLS-1, Sterile, Innovative Implant Technology, The Sinu-Lift(TM) System is intended to : - Facilitate access to the maxillary sinus, - Lift the sinus membrane from the alveolar ridge of the maxilla with a minimum height of 5mm, and - Augment the space created by lifting the maxillary sinus membrane with bone graft to supplement the maxillary alveolar crest with additional height needed for anchoring an implant.

    Recall: Z-0505-2009 · Initiated September 30, 2008

    Recall

    Recall Number
    Z-0505-2009
    Event Number
    50168
    Firm
    Innovative Implant Technology
    FEI Number
    3006005748
    Product Code
    NDP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 30, 2008
    Posted
    January 9, 2009
    Terminated
    October 1, 2009
    Address
    1825 Main St, Weston, FL, 33326-3683

    Description

    Sinu-Lift(TM) System, LLC., Model SLS-1, Sterile, Innovative Implant Technology, The Sinu-Lift(TM) System is intended to : - Facilitate access to the maxillary sinus, - Lift the sinus membrane from the alveolar ridge of the maxilla with a minimum height of 5mm, and - Augment the space created by lifting the maxillary sinus membrane with bone graft to supplement the maxillary alveolar crest with additional height needed for anchoring an implant.

    Reason

    Possible device failure: The cutter's shaft of the Sinu-Drill of the Sinu-Lift System could potentially get stuck inside the tap, thereby not allowing the cutter to spring out of the tap upon encountering the sinus membrane, increasing the possibility of perforating the sinus membrane.

    Action

    All consignees will be notified by letter entitled "URGENT: MEDICAL DEVICE RECALL" dated September 30, 2008, using priority mail. Consignees will also be contacted by telephone. Consignees will be asked to return the product using the prepaid FedEx label included with the letter. The returned product will be quarantined. For further information, please telephone Innovative Implant Technology at 305-975-4101

    Distribution

    Worldwide Distribution --- including USA and countries of Canada, Mexico, Japan, Australia, Japan, Egypt, and Turkey.

    Quantity

    299