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DGDE, DirectGuide Drill Extender. Instrument for use with… recallZ-0396-2016 · Implant Direct Sybron Manufacturing, LLC · initiated Oct 28, 2015

Class II Terminated All recalls posted in December 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Implant Direct Sybron Manufacturing, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.

FDA root cause category: Unknown/Undetermined by firm

What the company is doing

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.

Recall details

Recall number
Z-0396-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 28, 2015
Posted by the FDA
Dec 8, 2015
Recalling firm
Implant Direct Sybron Manufacturing, LLC
Quantity
478
Product code
NHA
FDA submissions
K081396
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 description

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

33 devices cleared under K081396 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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