Events

Recall of Device Recall ORTHO SENSOR

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

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
    63081
  • Event Risk Class
    Class 2
  • Event Number
    Z-0122-2013
  • Event Initiated Date
    2012-02-04
  • Event Date Posted
    2012-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112490
  • 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
    Intraoperative orthopedic joint assessment aid - Product Code ONN
  • Reason
    Ortho sensor in sunrise, fl is recalling the graphics user interface software 1.8 (which was updated to version 1.82, validated on 02/13/12). recall was initiated due to customer feedback which included the line of site between the knee ba lancer and the link station was obstructed by or metal stands or trays or the knee balancer device was placed atop of or near the metal stands or trays, interru.
  • Action
    Orthosensor did not provide a written customer notification. As the recall was reported to the FDA well after all nine of the products were corrected (the recall stemmed from an initial inspection of the firm), then no customer notification was requested. The removal and replacement of the previous version of the Graphic User Interface Software is being handled internally by members of Operations and the Sales force. The items the firm is recalling is software, and the software cannot be returned; the old version (version 1.8) would be erased. The new version 1.82 would be installed and downloaded into the equipment at the site during servicing. This does not involve the customer of which none are consignees. Effectiveness checks associated with the update of the software is being handled internally by the Operations and the Sales force. Further questions please call (813) 645-2855.

Device

Device Recall ORTHO SENSOR
  • Model / Serial
    Version 1.82
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of CA, FL, MI and NY.
  • Product Description
    "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" || Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. || Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.
  • Manufacturer
    Orthosensor

Manufacturer

Orthosensor
  • Manufacturer Address
    Orthosensor, 1560 Sawgrass Corporate Pkwy, 4th Floor, Sunrise FL 33323-2858
  • Manufacturer Parent Company (2017)
    OrthoSensor Inc.
  • Source
    USFDA