Recall Z-0122-2013 ยท ONN Intraoperative Orthopedic Joint Assessment Aid
Orthosensor
"****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.
| Date | Oct 24, 2012 (initiated Feb 4, 2012) |
| Status | Terminated |
| 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 |
| Root cause | 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 dow |
| Quantity | 9 |
| Distribution | Nationwide Distribution including the states of CA, FL, MI and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.