BEUDAMED
    FDA Enforcement Class II Terminated

    The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument)

    Recall: Z-1215-2015 · Reported March 4, 2015

    Enforcement

    Recall Number
    Z-1215-2015
    Event ID
    70291
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brainlab AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 4, 2015
    Initiation Date
    January 16, 2015
    Classification Date
    February 26, 2015
    Termination Date
    March 13, 2017
    Address
    Kapellenstrasse 12, N/A, Feldkirchen, N/A, N/A, Germany

    Description

    The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument)

    Reason

    The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.

    Code Info

    Model 52856 BL CURVED CUP INSERTER UNIVERSAL SHAFT; and MODEL 52856A BL OFFSET CUP IMPACTOR UNIVERSAL SHAFT, all serial/lot numbers distributed prior to January 13, 2015.

    Distribution

    Worldwide Distribution - US: Nationwide (AZ, CA, ID, IL, MD, MI, MN, OH, OK, OR, TN, WA, WI, WV); Australia, Austria, Bahrain, Belgium, Germany, Hong Kong, India, Italy, Japan, Malaysia, Russian Federation, Saudi Arabia, South Korea, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom

    Quantity

    114 offset cup impactors