Company:Orthosensor
Date of Enforcement Report 10/31/12
Class ll:
PRODUCT
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.Recall Number Z-0122-2013
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, interruption in the RF communications would occur momentarily.
RECALLING FIRM/MANUFACTURER
Orthosensor, Sunrise, FL on 2/4/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
9
DISTRIBUTION
Nationwide
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