BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.

    Recall: Z-1735-2022 · Reported September 21, 2022

    Enforcement

    Recall Number
    Z-1735-2022
    Event ID
    90727
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mako Surgical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2022
    Initiation Date
    August 8, 2022
    Classification Date
    September 9, 2022
    Termination Date
    May 22, 2026
    Address
    3365 Enterprise Ave, Weston, FL, 33331-3524, United States

    Description

    Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.

    Reason

    Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.

    Code Info

    Lot #22041607, UDI-DI (GTIN) 07613327407280.

    Distribution

    US Distribution was made to IL and AZ.

    Quantity

    2