BEUDAMED
    FDA Enforcement Class II Terminated

    Bone Dowell Harvest Tubes

    Recall: Z-2059-2017 · Reported May 17, 2017

    Enforcement

    Recall Number
    Z-2059-2017
    Event ID
    77113
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 17, 2017
    Initiation Date
    April 12, 2017
    Classification Date
    May 10, 2017
    Termination Date
    November 3, 2017
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    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.

    Code Info

    Part Number: 900738 Lot Number (LN): 889990

    Distribution

    No US distribution. JAPAN NETHERLANDS SINGAPORE SWITZERLAND

    Quantity

    49