BEUDAMED
    FDA Recall Terminated

    Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.

    Recall: Z-0196-2019 · Initiated November 15, 2017

    Recall

    Recall Number
    Z-0196-2019
    Event Number
    81090
    Firm
    Medacta Usa Inc
    FEI Number
    3006639916
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    November 15, 2017
    Terminated
    March 29, 2019
    Address
    3973 Delp St, Memphis, TN, 38118-6110

    Description

    Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.

    Reason

    Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.

    Action

    The firm initiated the recall by telephone to its distributors. The firm requested return of all recalled units.

    Distribution

    NC, ID, Belgium, Switzerland, Spain, Germany, Australia, France, Italy

    Quantity

    837 units