BEUDAMED
    FDA Recall Open, Classified

    Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.

    Recall: Z-2288-2025 · Initiated July 15, 2025

    Recall

    Recall Number
    Z-2288-2025
    Event Number
    97275
    Firm
    Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
    FEI Number
    3003386935
    Product Code
    JDG
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 15, 2025
    Posted
    August 11, 2025

    Description

    Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.

    Reason

    Inconsistent size terminology and color coding used on labeling

    Action

    Waldemar Link GmbH & Co. notified consignees of the recall via email on about 07/15/2025. Consignees were instructed to respond using the Distributor Reply form and arrange for the return of all affected product on hand.

    Distribution

    Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IN, KS, LA, NJ and the countries of Germany, Argentina, Belgium, Switzerland, Cyprus, Algeria, Finland, Hungary, Mexico, Netherlands, Peru, Slovenia, and Uruguay.

    Quantity

    46 units