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Ad-Tech Brain Implant Recall Gets FDA's Highest-Risk Status

Fri, 03/08/2013 - 7:29am
Mass Device

The FDA placed Class I risk status on Ad-Tech Medical Instrument Corp.'s recall of its Macro Micro Subdural Electrodes over concerns that the brain implants may cause injury to the brain.

MassDevice On Call

Federal healthcare regulators gave Ad-Tech Medical Instrument Corp.'s wide-reaching brain implant recall Class I status, the highest-risk category for medical device recalls.

Late last year the Wisconsin-based medical device maker recalled its Macro Micro Subdural Electrodes over concerns that the implanted devices could cause damage to the brain.

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