Implant Direct Sybron Recalls DirectGuide Drill Extender for Dental Implants
Implant Direct Sybron Manufacturing is recalling 26 lots of DirectGuide Drill Extenders because the drill may drop during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where a mechanical failure (dropping drill) could cause injury, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of the DGDE DirectGuide Drill Extender. This instrument is used with dental implants and adds a 6mm extension to accommodate specific tissue heights. The recall is being conducted because of a possible dropping of the drill.
The affected products were distributed worldwide, including nationwide in the United States and in Canada, Poland, Serbia, Italy, Germany, Cairo, Jordan, El Salvador, Kuwait, Costa Rica, Switzerland, Colombia, the United Kingdom, Austria, the Netherlands, Chile, and Egypt. The specific lot numbers involved are 61928, 64895, 64898, 64896, 65406, 65405, 65407, 65408, 65410, 65409, 65357, 67055, 67475, 67345, 37475, 67476, 67474, 67478, 67477, 67479, 65527, 68254, 68266, 68253, 68265, and 68262.
Healthcare professionals and patients should check their inventory or records for these specific lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or distributor for instructions on replacement or refund.
The recalled product
- 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…
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Affected units
- 478
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Parts Numbers: DGDE
- SPCST
- IBST
- BST
- CST
- ICST
- RBST
- RCST Lot Number: 61928
- 64895
- 64898
- 64896
- 65406
- 65405
- 65407
- 65408
- 65410
- 65409
- 65357
- 67055
- 67475
Distribution
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