BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated July 21, 2021

    Recall

    Recall Number
    Z-0122-2022
    Event Number
    88585
    Firm
    Implant Resource Inc
    FEI Number
    1000139815
    Product Code
    HXL
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    July 21, 2021
    Address
    917 Lone Oak Rd, Ste 1000, Eagan, MN, 55121-2266

    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

    Action

    Customers were initially contacted via email on 07/21/2021 to initiate the return of affected devices. A formal letter was sent to customers on 09/03/2021 via UPS. Instructions included to review the notification and ensure affected personnel are notified of the recall, immediately locate and quarantine any affected product in inventory, and to immediately return any affected product to Medical Products Resource.

    Distribution

    US distribution to Florida and New Hampshire

    Quantity

    6 units