Stryker - Sept. 24, 2010
Issue Date
Sep 24, 2010
Region
Central
Category
Device
$117.00
Address 1
Stryker Medical Division
Address 2
3800 E. Centre Ave.
City
Portage
State
MI
Zip/Postal Code
49002
Country
US
Inspection Range
Sep 15, 2010 - Sep 24, 2010
Pages
2
First Observation
An MDR report 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): Ryan J. Benedict, James A. Lane, Anthony R. Petriella, and Eric S. Pittman