BEUDAMED
    FDA Enforcement Class II Completed

    Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.

    Recall: Z-2251-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2251-2021
    Event ID
    88259
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 18, 2021
    Initiation Date
    June 29, 2021
    Classification Date
    August 12, 2021
    Address
    2320 Nw 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    Description

    Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.

    Reason

    Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).

    Code Info

    Serial Numbers: 6465619-6465640; 6465642-6465648

    Distribution

    US Nationwide Distribution

    Quantity

    30 devices