Genesys Orthopedic Systems, LLC - April 2, 2012
Issue Date
Apr 02, 2012
Region
Southwest
Category
Device
$117.00
Address 1
1250 S. Capital of Texas Hwy #600
Address 2
Bldg. #3
City
Austin
State
TX
Zip/Postal Code
78746-6446
Country
US
Inspection Range
Mar 21, 2012 - Apr 02, 2012
Pages
4
First Observation
An MDR was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Iris C. Macinnes