BEUDAMED
    FDA Recall Terminated

    PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis

    Recall: Z-0713-2017 · Initiated November 7, 2016

    Recall

    Recall Number
    Z-0713-2017
    Event Number
    75665
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    IQI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 7, 2016
    Terminated
    January 13, 2022
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    Description

    PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis

    Reason

    DeRoyal received complaints of mold on Tennis Elbow Straps.

    Action

    DeRoyal issued their recall on 11/7/16 to the physician / clinician level by sending recall letters to its direct accounts and sales representatives. The foreign customer was notified by email on 11/7/2016. The customers were asked to identify the affected products, destroy them and return the provided notice of destruction form to DeRoyal for credit.

    Distribution

    US Nationwide Distribution

    Quantity

    791 units