BEUDAMED
    FDA Recall Terminated

    Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S

    Recall: Z-0012-2007 · Initiated February 27, 2006

    Recall

    Recall Number
    Z-0012-2007
    Event Number
    36298
    Firm
    Integrated Orbital Implants Inc
    FEI Number
    3009688114
    Product Code
    HPZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 27, 2006
    Posted
    October 4, 2006
    Terminated
    October 5, 2006
    Address
    12625 High Bluff Dr, Ste 314, San Diego, CA, 92130-2054

    Description

    Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S

    Reason

    The end label on the outer box was mislabeled on 9 of a 10 unit lot. The end label says ''22 mm'' and the implants are actually ''20 mm''. The main label on the cardboard box applied by the contract packager is correct in identifying the product as ''20 mm''.

    Action

    The recall was to the distributor level. From contact with the two distributors involved, it was determined that all of the product affected was still with the two distributors. Both distributors affected were notified via email 2/27/2006. The correct labels were shipped by FEDEX to each of them. Both distributors were instructed to check their inventory of this lot number and confirm if the end labels were in conflict with the main outer box label. When this was confirmed, the distributor was instructed to apply the correct end labels supplied.

    Distribution

    Internationally to Finland & France

    Quantity

    8