BEUDAMED
    FDA Recall Completed

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

    Recall: Z-2251-2021 · Initiated June 29, 2021

    Recall

    Recall Number
    Z-2251-2021
    Event Number
    88259
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    LZO
    Status
    Completed
    Root Cause
    Under Investigation by firm
    Initiated
    June 29, 2021
    Posted
    August 12, 2021
    Address
    2320 Nw 66th Ct, Gainesville, FL, 32653-1630

    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).

    Action

    The firm notified their direct consignees on 06/29/2021 by email. The letter requested return of the affected devices. The firm will issue a letter through the sales representatives to the implanting physicians to follow-up with the patients beginning 07/23/2021.

    Distribution

    US Nationwide Distribution

    Quantity

    30 devices