BEUDAMED
    FDA Enforcement Class II Terminated

    Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00

    Recall: Z-0988-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-0988-2020
    Event ID
    84679
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2020
    Initiation Date
    December 23, 2019
    Classification Date
    February 4, 2020
    Termination Date
    September 10, 2020
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00

    Reason

    Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed the expiration date on the inner label

    Code Info

    Lot Numbers : 62754464, 62904231, 63060634

    Distribution

    US Nationwide

    Quantity

    133 units