BEUDAMED
    FDA Enforcement Class II Terminated

    Workstation, G2, Configured (P/N 000-0241)

    Recall: Z-2228-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2228-2019
    Event ID
    83299
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intellijoint Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 14, 2019
    Initiation Date
    June 28, 2019
    Classification Date
    August 8, 2019
    Termination Date
    September 16, 2020
    Address
    60 Bathurst Dr Unit 1, N/A, Waterloo, N/A, N/A, Canada

    Description

    Workstation, G2, Configured (P/N 000-0241)

    Reason

    Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the battery may overheat and pose a fire safety risk. To date, Intellijoint has distributed, 15-inch MacBook Pros which are the Workstation component (affected P/N 000-0241) in the Intellijoint HIP System.

    Code Info

    Apple MacBook Serial Numbers: C02R4A0ZG8WN, C02R4CTLG8WN, C02R4CVYG8WN, C02R4CTHG8WN, C02R4CUZG8WN, C02R4CV6G8WN, C02R4CWZG8WN Additional units discovered 09/18/2019: C02R4CQ5G8WN, C02R4CULG8WN, C02R4CVWG8WN, C02R4CWYG8WN, C02R4CQ6G8WN, C02R4CUPG8WN, C02R4CSSG8WN, C02R4CTQG8WN, C02R4CSZG8WN, C02R4CUSG8WN, C02R4CUXG8WN, C02R4CUQG8WN, C02R4CU0G8WN, C02R4A6PG8WN, C02R4CTMG8WN, 02R4CUNG8WN

    Distribution

    IL, CA, NY, TX, RI, Australia

    Quantity

    23 units