BEUDAMED
    FDA Enforcement Class II Ongoing

    MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868

    Recall: Z-0122-2022 · Reported October 27, 2021

    Enforcement

    Recall Number
    Z-0122-2022
    Event ID
    88585
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Implant Resource Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 27, 2021
    Initiation Date
    July 21, 2021
    Classification Date
    October 15, 2021
    Address
    917 Lone Oak Rd Ste 1000, N/A, Eagan, MN, 55121-2266, United States

    Description

    MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868

    Reason

    Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected

    Code Info

    Model Number: MPR-1120-1000, Lot Number: 200911-1-1

    Distribution

    US distribution to Florida and New Hampshire

    Quantity

    6 units