BEUDAMED
    FDA Enforcement Class II Ongoing

    Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.

    Recall: Z-0326-2025 · Reported November 13, 2024

    Enforcement

    Recall Number
    Z-0326-2025
    Event ID
    95568
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2024
    Initiation Date
    October 15, 2024
    Classification Date
    November 7, 2024
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.

    Reason

    The Bipolar assembly contains an oversized Retainer Ring.

    Code Info

    Batch W2401399, UDI-DI 03596010494375.

    Distribution

    International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.

    Quantity

    21 devices