BEUDAMED
    FDA Recall Terminated

    The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm

    Recall: Z-0925-05 · Initiated June 3, 2005

    Recall

    Recall Number
    Z-0925-05
    Event Number
    32335
    Firm
    BioHorizons Implant Systems Inc One Perimeter Park South
    FEI Number
    1000592496
    Product Code
    NDP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 3, 2005
    Posted
    June 23, 2005
    Terminated
    August 11, 2005
    Address
    Suite 230, South Birmingham, AL, 35243

    Description

    The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm

    Reason

    The product labeled as a Straight Permucosal Ext, 5mm x 3mm contained a profile abutment for Cement.

    Action

    The domestic consignees were contacted by telephone on 06/03/2005 to request the return of the products. The foreign consignee was contacted via telephone and email to request the same action.

    Distribution

    PA, TX, MI, VA and Russia

    Quantity

    5 units