BEUDAMED
    FDA Recall Terminated

    EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

    Recall: Z-0029-05 · Initiated October 4, 2004

    Recall

    Recall Number
    Z-0029-05
    Event Number
    30203
    Firm
    Implant Innovations, Inc.
    FEI Number
    1038806
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 4, 2004
    Posted
    October 21, 2004
    Terminated
    February 7, 2005
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200

    Description

    EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

    Reason

    The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.

    Action

    Begining on October 4, 2004 each direct account was contacted by email, faxed letter and telephone. They were informed of the recall and instructed to contact their customers if the product had been sold.

    Distribution

    Distributed to 34 direct accounts throughout the United States and four international accounts in Europe, Asia, South America and the middle East.

    Quantity

    216 units