BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025

    Recall: Z-0514-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0514-2020
    Event ID
    84148
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2019
    Initiation Date
    October 3, 2019
    Classification Date
    November 22, 2019
    Termination Date
    April 21, 2022
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006, United States

    Description

    Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025

    Reason

    Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)

    Code Info

    Lot Number: G6091225, Exp. Date: 2022-06 UDIs: (01)04546540167712(17)220618(10)

    Distribution

    Foreign: Australia, France, Finland, Germany, Italy, Japan, New Zealand, Netherlands, Norway, Romania, Spain, Sweden and UK

    Quantity

    40 units