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Recall Observatory FDA recall evidence

Device product

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.

Z-0396-2016

October 28, 2015

Class II

Product summary

Firm
Implant Direct Sybron Manufacturing, LLC
Event
Event 72549
Status
Terminated
Classification
Class II
Quantity
478
Official record key
device-enforcement:Z-0396-2016

Official wording

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

Code information: Parts Numbers: DGDE, 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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