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Medical device alert issued for Greatbatch Standard Offset Cup Impactor
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Action is underway to identify Standard Offset Cut Impactors manufactured by Greatbatch and distributed in England, Northern Ireland, Scotland and Wales following a recent Medicines and Healthcare Products Regulatory Agency medical device alert issued for sterilization problems with the implants.
The medical device alert (MDA/2014/031) stated there is potential for infection due to inadequately sterilized devices.
Greatbatch has validated new sterilization parameters for all lots of the device, which is distributed by JRI Limited and Stryker UK Limited, to address the issue. The parameters for sterilization were provided in a manufacturer’s Field Safety Notice (FSN) issued March 2014.
All staff involved in the sterilization of these devices are being asked to identify the devices affected and follow the updated sterilization instructions described in the FSN.
The MDA also contains specific by-country information for inquiring about technical and clinical aspects of this notice to the Medicines and Healthcare Products Regulatory Agency.