Z-0396-2016Class II

DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a...

Name: Z-0396-2016 DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a...
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2015-10-28
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2015-10-28 / Terminated / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of 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... on 2015-10-28. FDA classified it as Class II and gives the reason as "Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0396-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-28
Posted: 2015-12-08
Terminated: 2016-04-08
Recalling firm: Implant Direct Sybron Manufacturing LLC
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.
Product code: NHA Abutment, Implant, Dental, Endosseous
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.
Root cause tag: manufacturing process
FDA root cause: Unknown/Undetermined by firm
Action: On 10/28/15 customer notification letters were sent. Within the letter the firm states that if customers have any of the affected product listed to contact the firm's Customer Care at 1-888-649-6425. A return label is provided with notification. The firm states that if customers are an authorized Implant Direct Sybron Manufacturing distributor they request that they identify their customers that have been shipped the affected product, and contact them within 48 hours of receiving notification in order to obtain the product. The letter states if any customers or patients have experienced any issues as a result of the affected products to report the incident to the FDA through he MEDWATCH reporting system.
Quantity in commerce: 478
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0396-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0396-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-08

Product code NHA

K081396Class IISwissplant Dental Implant SystemImplant Direct, LLC / cleared 2009-01-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)