FDAFDA · Food and drugs·Recall number Z-0122-2013
"****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.
Published October 31, 2012 · Recall initiated: February 4, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Orthosensor
- Distributor
- Nationwide Distribution including the states of CA, FL, MI and NY.
- Lot
- Version 1.82
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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