The QMN Weekly Bulletin
Quality / Medical Devices / Postmarket Safety

Greatbatch Issues Field Corrective Action for Standard Offset Cup Impactor

March 28, 2014
Minneapolis, Minn.-based Greatbatch has issued a field corrective action for its Standard Offset Cup Impactor, after a sterility level of 10-6 was not achieved when the device was subjected to steam sterilization cycles during a recent design and manufacturing transfer, company spokesman Christopher Knospe told Device Daily Bulletin.
Device Daily Bulletin