BEUDAMED
    FDA Recall Terminated

    Bone Dowell Harvest Tubes

    Recall: Z-2059-2017 · Initiated April 12, 2017

    Recall

    Recall Number
    Z-2059-2017
    Event Number
    77113
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 12, 2017
    Posted
    April 25, 2017
    Terminated
    November 3, 2017
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Bone Dowell Harvest Tubes

    Reason

    mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part.

    Action

    On 4/12/2017 URGENT MEDICAL DEVICE RECALL REMOVAL 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

    No US distribution. JAPAN NETHERLANDS SINGAPORE SWITZERLAND

    Quantity

    49