Orthofix, Inc. - June 24, 2011
Issue Date
Jun 24, 2011
Region
Southwest
Category
Device
$117.00
Address 1
3451 Piano Pkwy
City
Lewisville
State
TX
Zip/Postal Code
75056
Country
United States
Inspection Range
Jun 20, 2011 - Jun 24, 2011
Pages
2
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Iris C. Macinnes