FDA-Device2015-12-16Class II
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.
Implant Direct Sybron Manufacturing, LLC
Hazard
Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.
Sold states
Worldwide Distribution- US (nationwide) including the states of CA, FL, TX, MO, MI, MA, NV, OR, PA, AZ, IL, VA, OH, GA, and SC, and the country of Canada, Poland, Serbia, Italy, Germany, Cairo, Jordan, El Salvador, Kuwait, Costa Rica, Switzerland, Colombia, United Kingdom, Austria, Netherlands, Chile, and Egypt.
Affected count
478
Manufactured in
3050 E Hillcrest Dr, N/A, Westlake Village, CA, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0396-2016Don't want to check this manually?
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