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U.S. Department of Health and Human Services

Class 2 Device Recall Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD

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  Class 2 Device Recall Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD see related information
Date Initiated by Firm May 02, 2017
Create Date May 22, 2017
Recall Status1 Terminated 3 on January 08, 2018
Recall Number Z-2125-2017
Recall Event ID 77171
510(K)Number K061319  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Code Information 89103, 83493, 78986
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 is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Implant Direct sent an Urgent Medical Device Field Corrective recall letter dated April 2017 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are informed that the product may be out of Implant Direct specification. The abutment should have a full hex configuration from end of part to shoulder (1.6mm). When the part is in-correct there will be a noticeable diameter ring just above shoulder and a hex flat face that appears short (@ 1.1mm) not allowing full engagement to implant analog. This discrepancy may lead to the possibility of the abutment not seating properly on the implant, and if undetected may lead to micro-leakage and a possible infection to the patient. Customers are instructed to complete and return the Acknowledgement and Recall Return form within 48 hrs. Customers with any questions are instructed to contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.
Quantity in Commerce 151 units
Distribution Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan
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 = DZE and Original Applicant = IMPLANT DIRECT LLC
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