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Class 2 Device Recall ImplantDirect simply InterActive Implant, Part 653211U |
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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
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Product Classification |
Implant, Endosseous, Root-Form - Product Code DZE
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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/ Manufacturer |
Implant Direct Sybron Manufacturing, LLC 3050 E Hillcrest Dr Thousand Oaks CA 91362
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For Additional Information Contact |
Jose Trejo 818-444-3300 Ext. 3543
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Manufacturer Reason for Recall |
The main vial label lists the incorrect part number, but the cap label is correct.
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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
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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.
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510(K) Database |
510(K)s with Product Code = DZE and Original Applicant = IMPLANT DIRECT SYBRON MANUFACTURING LLC
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