BEUDAMED
    FDA Enforcement Class II Ongoing

    AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000

    Recall: Z-2331-2021 · Reported September 1, 2021

    Enforcement

    Recall Number
    Z-2331-2021
    Event ID
    88223
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 1, 2021
    Initiation Date
    June 28, 2021
    Classification Date
    August 23, 2021
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000

    Reason

    Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery.

    Code Info

    Part number/ Lot number: 1. 520-08-000 / 85OU1108; 85OU1110; 85OU1111, 2. 520-10-000 / 851U1256; 851U1257; 851U1258; 851U1259, 3. 520-12-000 / 852U1402; 852U1393; 852U1404; 852U1395; 852U1398A, 852U1405; 852U1397; 852U1391; 852U1400; 852U1398; 852U1407; 852U1396; 852U1406, 4. 520-14-000 / 853U1234; 853U1240; 853U1241A; 853U1238; 853U1239; 853U1237; 853U1241, 5. 520-16-000 / 854U1076; 854U1077

    Distribution

    US: AL,AR,AZ,CA,CO,FL,GA,HI,IL,IN,KY,LA,MD,ME,MI,MN,MO,MS,MT,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,TN,TX,UT,VA,WA,WV OUS: N/A

    Quantity

    N/A