FDAMay 2, 2018device

AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The Cranial Drill Bits and a...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.

What to do

FDA enforcement status: Terminated

Brands named

ad tech medical instrument

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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