BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2288-2025 · Reported August 20, 2025

    Enforcement

    Recall Number
    Z-2288-2025
    Event ID
    97275
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Waldemar Link GmbH & Co. KG (Mfg Site)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 20, 2025
    Initiation Date
    July 15, 2025
    Classification Date
    August 11, 2025
    Address
    Oststr. 4-10, N/A, Norderstedt, N/A, N/A, Germany

    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

    Code Info

    Item Number: 198-828/04. UDI-DI: 04026575193783. Serial Numbers: 211117/0069, 211117/0070, 211117/0071, 211117/0073, 211117/0078, 220204/0613, 220204/0614, 220204/0615, 220204/0616, 220204/0617, 220204/0618, 220204/0619, 220204/0620, 220204/0621, 220204/0622, 220204/0623, 220204/0624, 220204/0627, 220304/0074, 220304/0075, 220304/0076, 220304/0077, 220304/0078, 220304/0080, 220304/0081, 220304/0082, 220304/0083, 220517/0052, 220517/0069, 220517/0070, 220517/0071, 220517/0072, 220517/0073, 220517/0074, 220517/0076, 220517/0078, 220517/0079, 220517/0080, 220517/0081, 220517/0085, 220517/0088, 220517/0089, 220517/0090, 221011/0093, 240415/3890, 240415/3896.

    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