Important Safety Alerts

The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Standard Offset Cup Impactor manufactured by Greatbatch Medical. The affected device was manufactured from January 2004 through January 2013 and distributed from January 2004 through December 2013.

The manufacturer has identified through internal Sterility Assurance Level validation testing that a sterility assurance level of 10-6 is not achieved on the Standard Offset Cup Impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current Instructions For Use provided with the device. The manufacturer has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.

Greatbatch has developed new sterilization recommendations that meet acceptable sterility assurance levels (AAMI ST79 standard). Customers who have the affected product should immediately begin utilizing the new sterilization instructions.

For details, please refer to the following FDA websites:

• http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1119-2014&w=03122014&lang=eng
• http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm388928.htm
• http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm389005.htm
• http://www.fda.gov/Safety/Recalls/ucm388883.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 13 March 2014