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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 653211Usee related information
Date Initiated by FirmMarch 03, 2017
Create DateJuly 26, 2018
Recall Status1 Terminated 3 on August 06, 2018
Recall NumberZ-2551-2018
Recall Event ID 79855
510(K)NumberK130572 
Product Classification Implant, Endosseous, Root-Form - Product Code DZE
ProductImplantDirect, 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
For Additional Information ContactJose 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
ActionRecall 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 Commerce124 units
DistributionDistribution 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 CycleTPLC 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) Database510(K)s with Product Code = DZE
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