BEUDAMED
    FDA Recall Terminated

    Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer

    Recall: Z-2292-2010 · Initiated June 7, 2010

    Recall

    Recall Number
    Z-2292-2010
    Event Number
    56329
    Firm
    Integrated Orbital Implants Inc
    FEI Number
    3009688114
    Product Code
    HPZ
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    June 7, 2010
    Posted
    August 26, 2010
    Terminated
    August 31, 2010
    Address
    12625 High Bluff Dr, Ste 300, San Diego, CA, 92130-2054

    Description

    Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer

    Reason

    Integrated Orbital Implants, Inc. has initiated a recall of it's Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer due to a labeling issue in which the expiration date of the product was omitted.

    Action

    Customers were contacted by telephone and email

    Distribution

    USA (MT, AL, IN, IA, NY, KY, IL, MI, and FL), Canada, Germany, and Turkey

    Quantity

    40 units