BEUDAMED
    FDA Recall Terminated

    Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box

    Recall: Z-2475-2020 · Initiated June 18, 2020

    Recall

    Recall Number
    Z-2475-2020
    Event Number
    85884
    Firm
    Mueller Sports Medicine, Inc
    FEI Number
    2110420
    Product Code
    ITQ
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    June 18, 2020
    Terminated
    October 29, 2021
    Address
    1 Quench Dr, Prairie Du Sac, WI, 53578-2100

    Description

    Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box

    Reason

    Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex".

    Action

    Mueller Sports sent notification letters to both customers and distributors dated, 6/12/2020, and titled, "URGENT MEDICAL DEVICE RECALL". The letter indicate that Natural Rubber was present in the Hybrid Wraparound Knee Support and the product is labeled with the statement: Not made with Natural Rubber Latex. The firm initiated a voluntary recall and is notifying customers of the issue. Customers should immediately discontinue use of any product identified in the letter. If customers have affected product, they need to complete the enclosed Recall Acknowledgment Form and fax to Mueller Sports Medicine at 1-800-852-4334 Attention Recall. Once the fax is received, the firm will provide instructions on how to return or dispose of the affected product.

    Distribution

    U.S. distribution only: AR and OH.

    Quantity

    135,354 units