BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.

    Recall: Z-0393-2019 · Reported November 14, 2018

    Enforcement

    Recall Number
    Z-0393-2019
    Event ID
    81072
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 14, 2018
    Initiation Date
    August 22, 2018
    Classification Date
    November 6, 2018
    Termination Date
    June 17, 2021
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.

    Reason

    Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.

    Code Info

    Lot Expiry Date Before: 09/18/2023

    Distribution

    Worldwide distribution: US Nationwide, Canada Argentina Australia Belgium Brazil Chile Colombia Costa Rica Czech Republic Dominican Republic Ecuador Finland France China Ecuador Germany Greece Hong Kong Indonesia Italy Japan Jordan Korea Lebanon Malaysia Netherland Paraguay Peru Singapore South Africa Spain Sweden Switzerland Thailand Trinidad and Tobago Turkey United Arab Emirates United Kingdom Uruguay Vietnam

    Quantity

    12825 units