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U.S. Department of Health and Human Services

Class 2 Device Recall ImplantDirect simply InterActive Implant, Part 655010U

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  Class 2 Device Recall ImplantDirect simply InterActive Implant, Part 655010U see related information
Date Initiated by Firm March 14, 2018
Create Date May 23, 2018
Recall Status1 Terminated 3 on June 04, 2018
Recall Number Z-1917-2018
Recall Event ID 79793
510(K)Number K130572  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL.

Product Usage: Usage:
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 #68960
Recalling Firm/
Manufacturer		 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 cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
FDA Determined
Cause 2		 Labeling mix-ups
Action The recall letter dated 3/16/2018 was first issued via email to one of the foreign consignees on 3/14/2018. The U.S. and other foreign consignees were mailed letters on 3/16/2018 via FedEx overnight mail. the letter identified the affected product, problem and actions to be taken.
Quantity in Commerce 298 implants
Distribution Worldwide Distribution - US Nationwide in the state of AZ, CA, CO, FL, ID, IL, KY, NC, NE, NY, OK, OR, TN, TX, UT, VA, WA, and WI. Foreign distribution was made to Canada, Japan, United Kingdom, France, Switzerland, Netherlands, and Germany.
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
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