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U.S. Department of Health and Human Services

Class 2 Device Recall ImplantDirect simply InterActive Implant, Part 653211U

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  Class 2 Device Recall ImplantDirect simply InterActive Implant, Part 653211U see related information
Date Initiated by Firm March 03, 2017
Create Date July 26, 2018
Recall Status1 Terminated 3 on August 06, 2018
Recall Number Z-2551-2018
Recall Event ID 79855
510(K)Number K130572  
Product Classification Implant, Endosseous, Root-Form - Product Code DZE
Product ImplantDirect, Dental implants 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 #87837
Recalling Firm/
Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Thousand Oaks CA 91362
For Additional Information Contact Jose Trejo
818-444-3300 Ext. 3543
Manufacturer Reason
for Recall
The main vial label lists the incorrect part number, but the cap label is correct.
FDA Determined
Cause 2
Process control
Action Recall notifications dated 2/13/2017 were issued to U.S. consignees via UPS overnight on 3/3/2017. Foreign consignees received letters on 3/13/2017 and 3/14/2017.
Quantity in Commerce 124 units
Distribution Distribution was made to AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, and WA. There was no government/military distribution. Foreign distribution was made to Switzerland, Germany, Lithuania, and Spain.
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 SYBRON MANUFACTURING LLC