www.fdanews.com/articles/163417-greatbatch-issues-field-corrective-action-for-standard-offset-cup-impactor
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
Device Daily Bulletin