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U.S. Department of Health and Human Services

Class 2 Device Recall Implant Direct, INTERACTIVE HEALING COLLAR

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  Class 2 Device Recall Implant Direct, INTERACTIVE HEALING COLLAR see related information
Date Initiated by Firm January 23, 2018
Create Date February 06, 2018
Recall Status1 Terminated 3 on August 09, 2018
Recall Number Z-0539-2018
Recall Event ID 78917
510(K)Number K130572  
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
Product Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Code Information Lot Number 104203
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information Contact Customer Care Team
818-444-3300 Ext. 3323
Manufacturer Reason
for Recall		 InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.
FDA Determined
Cause 2		 Process control
Action The firm initiated their recall on 01/23/2018 by letter. the recall notices requested the following actions by the distributors: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form with the affected product, if available, within 48 hours. 3. If you are an authorized Implant Direct Sybron Manufacturing distributor, we request that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of this notification in order to provide the customers with replacement product." The letter disseminated to the physician requested the following actions: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form with the affected product, if available, within 48 hours."
Quantity in Commerce 55 units
Distribution CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands
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 = NHA and Original Applicant = IMPLANT DIRECT SYBRON MANUFACTURING LLC
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