FDAOctober 28, 2015device

DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.

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

The hazard

Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.

What to do

FDA enforcement status: Terminated

Brands named

implant direct sybron manufacturingimplantimplant direct

Recall history

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

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