Events

Recall of Device Recall Brainlab AG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Brainlab AG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70291
  • Event Risk Class
    Class 2
  • Event Number
    Z-1215-2015
  • Event Initiated Date
    2015-01-16
  • Event Date Posted
    2015-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132865
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Orthopedic stereotaxic instrument - Product Code OLO
  • Reason
    The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
  • Action
    FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letters dated December 11, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to utilize the sterilization cycles included in the letter. Customers were further advised to alert users of these devices to the sterilization process changes. Customers with questions can contact Brainlab by telephone at 800-597-5911 or via e-mail at us.support@brainlab.com.

Device

Device Recall Brainlab AG
  • Model / Serial
    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.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product 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)
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Manufacturer Address
    Brainlab AG, Kapellenstrasse 12, Feldkirchen Germany
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    USFDA