BEUDAMED
    FDA Enforcement Class II Terminated

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815

    Recall: Z-0684-2022 · Reported March 9, 2022

    Enforcement

    Recall Number
    Z-0684-2022
    Event ID
    89605
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioPro, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2022
    Initiation Date
    February 1, 2022
    Classification Date
    February 28, 2022
    Termination Date
    February 28, 2024
    Address
    2929 Lapeer Rd, Port Huron, MI, 48060-2558, United States

    Description

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815

    Reason

    There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

    Code Info

    Lot Number: 124738, 127602; UDI: 00810012480109

    Distribution

    US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.