BEUDAMED
    FDA Enforcement Class II Terminated

    FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.

    Recall: Z-1130-2014 · Reported March 12, 2014

    Enforcement

    Recall Number
    Z-1130-2014
    Event ID
    67468
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Djo Surgical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    March 12, 2014
    Initiation Date
    February 7, 2014
    Classification Date
    March 4, 2014
    Termination Date
    October 1, 2014
    Address
    9800 Metric Blvd, Austin, TX, 78758-5445, United States

    Description

    FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.

    Reason

    Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the products being mislabeled. The units labeled as Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 on the outside and containing Model/Catalog Number 932-36-252, Lot# 728F1089 on the inside (1

    Code Info

    Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 (an MP5 Non-Hooded, Neutral Liner) were mistakenly packaged/labeled as Model/Catalog Number 932-36-252, Lot# 728F1089 (an MP7 10-degree Hooded Liner) and vice-versa

    Distribution

    Nationwide Distribution - USA including TX, LA, FL, CA, and AZ.

    Quantity

    10 units of Model/Catalog Number 931-28-248 Lot/Serial Number(s) 685F1034 labeled asModel/Catalog Number 932-36-252, Lot# 728F1089