Reported Dec 16, 2015 · Terminated

DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm…

Implant Direct Sybron Manufacturing, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Implant Direct Sybron Manufacturing, LLC · 3050 E Hillcrest Dr · Westlake Village, CA · 91362-3171

Is this the product you have?

  • 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.
Lot codes and dates
  • Parts NumbersDGDE, SPCST, IBST, BST, CST, ICST, IBST, RBST
  • RCST Lot Number
    • 61928
    • 64895
    • 64898
    • 64896
    • 65406
    • 65405
    • 65407
    • 65408
    • 65410
    • 65409
    • 65357
    • 67055
    • 67475
    • 67345
    • 37475
    • 67476
    • 67474
    • 67478
    • 67477
    • 67479
    • 67527
    • 68254
    • 68266
    • 68253
    • 68265
    • 68262
Amount recalled
478

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 8, 2016 · Data as of Sep 19, 6:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.