Greatbatch Medical Informs Customers Its Standard Offset Cup Impactor Must Be Wrapped for Sterilization

Greatbatch Medical, held by Integer Holdings, told its distributors and customers by overnight mail that the Standard Offset Cup Impactor with POM-C Handle grip should be individually wrapped during sterilization processing.

The device failed sterility testing when housed in a dedicated instrument case using the IFU recommended sterilization procedures, the company said on Wednesday, adding the dedicated instrument case is not manufactured by Greatbatch Medical.

The company said an internal review determined that the sterilization recommendations in the Instructions for Use for the product, which were developed for individually wrapped devices, did not meet requirements for sterility assurance level when sterilized in an instrument case, potentially resulting in surgical infection. Devices may be successfully sterilized according to the recommendations when individually wrapped and no incidents have been reported during clinical use of the product and no adverse events have been reported, the company said.

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