BEUDAMED
    FDA Recall Terminated

    Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin

    Recall: Z-2056-2017 · Initiated April 13, 2017

    Recall

    Recall Number
    Z-2056-2017
    Event Number
    77116
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LOD
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 13, 2017
    Posted
    April 25, 2017
    Terminated
    March 26, 2019
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin

    Reason

    Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device.

    Action

    On 4/13/2017 URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.

    Distribution

    TX. Japan Mexico

    Quantity

    4238