Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DGDE Recalled by Implant Direct Sybron Manufacturing, LLC Due to Implant Direct Sybron Manufacturing, LLC is recalling 26...

Date: October 28, 2015
Company: Implant Direct Sybron Manufacturing, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Implant Direct Sybron Manufacturing, LLC directly.

Affected Products

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.

Quantity: 478

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Implant Direct Sybron Manufacturing, LLC

Implant Direct Sybron Manufacturing, LLC has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report