BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.

    Recall: Z-0975-2014 · Reported February 19, 2014

    Enforcement

    Recall Number
    Z-0975-2014
    Event ID
    67384
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2014
    Initiation Date
    December 6, 2013
    Classification Date
    February 12, 2014
    Termination Date
    May 6, 2015
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2002, United States

    Description

    Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.

    Reason

    Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.

    Code Info

    510 K103010 Catalog # 5444-0-400 Lot Code K08702VR21FEB

    Distribution

    Distributed in PA.

    Quantity

    one unit