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.
The corrective action affects 4,889 products manufactured and distributed to customers in the U.S., the UK, China, Japan and 16 other countries between 2004 and 2013.
No adverse events have been reported and the company is cooperating with the FDA, Greatbatch says. The company has since provided its customers with new sterilization instructions that meet its standards.
Greatbatch develops and manufactures cardiac, neuromodulation, orthopedic and vascular medical devices, as well as batteries for portable medical devices. The Standard Offset Cup Impactor is used to implant acetabular cups during minimally invasive total hip arthroplasty procedures.
View the FDA safety notice at www.fdanews.com/ext/resources/files/03/03-14-14-Greatbatch.pdf. — Lena Freund
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