"****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.
Publicado el 31 de octubre de 2012 · Inicio del retiro: 4 de febrero de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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
Qué hacer
Voluntary: Firm initiated · Telephone
Detalles del retiro
- Fabricante
- Orthosensor
- Distribuidor
- Nationwide Distribution including the states of CA, FL, MI and NY.
- Lote
- Version 1.82
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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