BEUDAMED
    FDA Enforcement Class II Terminated

    Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.

    Recall: Z-1495-2017 · Reported March 29, 2017

    Enforcement

    Recall Number
    Z-1495-2017
    Event ID
    76442
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 29, 2017
    Initiation Date
    February 14, 2017
    Classification Date
    March 20, 2017
    Termination Date
    November 3, 2017
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.

    Reason

    Digital templates were created with the incorrect files.

    Code Info

    Orthosize Templating Version 1.2.6

    Distribution

    Worldwide distribution. US Nationwide including Puerto Rico, Canada, Argentina, Australia, Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.

    Quantity

    3232