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U.S. Department of Health and Human Services

Class 2 Device Recall Certain Bellatek Encode

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  Class 2 Device Recall Certain Bellatek Encode see related information
Date Initiated by Firm January 10, 2020
Create Date February 26, 2020
Recall Status1 Terminated 3 on August 02, 2021
Recall Number Z-1369-2020
Recall Event ID 84771
510(K)Number K072642  
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
Product CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H)
Reference Number: IEHA353
Code Information Lot Numbers: 1228667 
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Zimmer Biomet
888-800-8045
Manufacturer Reason
for Recall		 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
FDA Determined
Cause 2		 Process control
Action Zimmer Biomet issued letter to Distributors, Clinicians via FedX on 1/10/20 stating reason for recall, health risk and action take: Step 1: Quarantine any unused affected products in your inventory for return to Zimmer Biomet Dental. Step 2: Identify any patients currently in your care who have received an affected Certain Encode Healing Abutment with the lot numbers in Table 1. a)If the lot number of the Certain BellaTek Encode Healing Abutment is known: a.If the patient has not yet undergone scanning/impressioning, the affected Certain BellaTek Encode Healing Abutment should be replaced with a new Certain BellaTek Encode Healing Abutment prior to scanning/impressioning. Please contact Zimmer Biomet Dental at the number provided in Step G below for an immediate replacement Certain BellaTek Encode Healing Abutment. b.If the case has already been started and the scan/impression has been sent to a lab, please ask the lab to call BellaTek Customer Service team at the number referenced in Step G below for instructions on how to remediate the case. The lab will not be charged twice for the BellaTek abutment. b)If the lot number of the Certain BellaTek Encode Healing Abutment is unknown, inspect for the product condition using Attachment 2. a.If the referenced product condition is present, please follow the instructions in Step 2a above. The affected healing abutment must be returned to Zimmer Biomet Dental per the below instructions. b.If the referenced condition is not present, reinsert the original healing abutment and release the patient. Complete certificate of Acknowledgement and email to CorporateQuality.PostMarket@zimmerbiomet.com. Questions or concerns call the BellaTek Customer Service team at 1-888-800-8045 between 8:00 am and 5:00pm EST, Monday through Friday.
Distribution Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
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 = BIOMET 3I, INC.
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