Stryker Orthopaedics - June 19, 2009
Issue Date
Jun 19, 2009
Region
Central
Category
Device
$117.00
Address 1
325 Corporate Dr.
City
Mahwah
State
NJ
Zip/Postal Code
7430
Country
US
Inspection Range
May 28, 2009 - Jun 16, 2009
Pages
3
First Observation
Corrective and preventive action procedures have not been implemented. Specifically, changes to Surgical Protocols (including changes associated with corrective actions) are controlled through the firm's Procedure for Surgical Protocols, Document No. D00028 and Procedures for Review and Approval of Marketing Materials, Document No. RP3000.
Investigator(s): Dennis Guilfoyle, Li Li, and Robert G. Ruff