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U.S. Department of Health and Human Services

Class 2 Device Recall ImplantDirect Legacy 3 Implant

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  Class 2 Device Recall ImplantDirect Legacy 3 Implant see related information
Date Initiated by Firm August 08, 2018
Create Date October 01, 2019
Recall Status1 Terminated 3 on October 07, 2019
Recall Number Z-0018-2020
Recall Event ID 83518
510(K)Number K090234  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216.

The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Code Information Lot number 110350
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information Contact Ms. Elizabeth Dunn (USA)
888-649-6425 Ext. 5467
Manufacturer Reason
for Recall		 Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.
FDA Determined
Cause 2		 Employee error
Action Recall letters dated 8/8/2018 were issued on 8/8/2018 via FedEx overnight mail to the U.S. and Canadian consignees and via email to the UAE consignee.
Quantity in Commerce 22 vials
Distribution Worldwide distribution - US Nationwide including the states of CO, HI, ID, KS, NC, OH, OR, PA, SC, TN, and UT, and countries of Canada and the United Arab Emirates.
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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