BEUDAMED
    FDA Enforcement Class II Terminated

    CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9

    Recall: Z-0593-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0593-2018
    Event ID
    79024
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2018
    Initiation Date
    July 12, 2017
    Classification Date
    February 12, 2018
    Termination Date
    May 20, 2019
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994, United States

    Description

    CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9

    Reason

    Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).

    Code Info

    Part No. 3L93709 and Lot No. 5291990

    Distribution

    Nationally; US Consignees for this recall are the affected are US Distributors and US Medical Facilities (Hospitals/User Facilities) that may have purchased, used, or received the affected device.

    Quantity

    21 Units