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U.S. Department of Health and Human Services

Class 2 Device Recall DGDE, DirectGuide Drill Extender

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  Class 2 Device Recall DGDE, DirectGuide Drill Extender see related information
Date Initiated by Firm October 28, 2015
Date Posted December 08, 2015
Recall Status1 Terminated 3 on April 08, 2016
Recall Number Z-0396-2016
Recall Event ID 72549
510(K)Number K081396  
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
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.
Code Information 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
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information Contact
818-444-3300 Ext. 3323
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NHA and Original Applicant = IMPLANT DIRECT LLC
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