Events

Recall of Universal Optical Tracker Fixation

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

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
    49122
  • Event Risk Class
    Class 2
  • Event Number
    Z-2445-2008
  • Event Initiated Date
    2007-08-06
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-03-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72809
  • 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
    Stereotaxic instrument - Product Code HAW
  • Reason
    Inadequate weld on tracker, knob oversized and poor thread design on attachment screw results in seizing. the instrument may break during use, resulting in surgical delay and an increased risk of infection.
  • Action
    Firm's sales representatives were notified via e-mail on 8/6/07 to review their inventory and that of their accounts and to notify the firm of their location so that they could be replaced. Contact the firm by telephone at 574-267-6131 for additional information concerning this recall.

Device

Universal Optical Tracker Fixation
  • Model / Serial
    Lots 050433, BP050199, BP050258 and BP050350.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including states of California, Florida and Washington.
  • Product Description
    Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. Surgical instrument.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Manufacturer Address
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA