FDA Device recall Z-0396-2016
DGDE, DirectGuide Drill Extender
- FDA Device
- Class II
- terminated
- Published 2015-12-16
On 2015-12-16 the FDA classified a Class II recall of DGDE, DirectGuide Drill Extender by Implant Direct Sybron Manufacturing, citing implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0396-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-28 |
| Published | 2015-12-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | US |
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.
Reason
Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.
Identifiers
| code_info | Parts Numbers: DGDE, SPCST, IBST, BST, CST, ICST, IBST, RBST, RCST Lot Number: 61928, 64895, 64898, 64896, 65406, 6…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class II · 2020-02-19 · Implant Direct Sybron Manufacturing
All Implant Direct Sybron Manufacturing recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0396-2016%22
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