I agree with bb254, that an Engineering Change Order may be necessary, especially since the design controls have been finished for this project. In that ECO, it would most likely call for a change for that defective part causing the device’s failure to activate. Most likely there would be a change in the specification, since you’re changing one input in order to affect the output. In this case, that changed part would be the input resulting in a more accurate output of the device’s ability to function. It will be necessary to revisit the Planning Phase as this calls for a change in some aspect of the design because of the ECO. Primarily the Executing Phase of the Project process may be affected since Design Verification will need to be conducted once more in order to ensure that this part is not defective. Risk Management and the Monitoring & Control Process really looks manages this recall because the purpose is to either mitigate or eliminate this risk.