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U.S. Department of Health and Human Services

Class 2 Device Recall ORTHO SENSOR

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  Class 2 Device Recall ORTHO SENSOR see related information
Date Initiated by Firm February 04, 2012
Date Posted October 24, 2012
Recall Status1 Terminated 3 on December 12, 2012
Recall Number Z-0122-2013
Recall Event ID 63081
Product Classification Intraoperative orthopedic joint assessment aid - Product Code ONN
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.
Code Information Version 1.82
Recalling Firm/
Manufacturer		 Orthosensor
1560 Sawgrass Corporate Pkwy
4th Floor
Sunrise FL 33323-2858
For Additional Information Contact Juan C. Fernandez
813-6452855
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 9
Distribution Nationwide Distribution including the states of CA, FL, MI and NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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