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Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004. The firm 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 (IFU) provided with the device. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. This recalled product may cause serious adverse health consequences, including death. For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm389005.htm
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