FDAFDA · Food and drugs·Recall number Z-0396-2016
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.
Published December 16, 2015 · Recall initiated: October 28, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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