DGDE — Class II medical device recall Z-0396-2016
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2015-12-16, distributed nationwide. Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a
| Recall number | Z-0396-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC, Westlake Village, CA, United States |
| Recall initiated | 2015-10-28 |
| Classified | 2015-12-08 |
| Reported by FDA | 2015-12-16 |
| Terminated | 2016-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CH, CL, CO, CR, DE, EG, GB, IT, JO, KW, NL, PL, RS, SV |
| Quantity | 478 |
| Lot numbers | 37475, 61928, 64895, 64896, 64898, 65357, 65405, 65406, 65407, 65408, 65409, 65410, 67055, 67345, 67474, 67475, 67476, 67477, 67478, 67479, 67527, 68253, 68254, 68262, 68265, 68266 |
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 for recall
Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0396-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.