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U.S. Department of Health and Human Services

Class 2 Device Recall Rhondium OVC3 One Visit Crown

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  Class 2 Device Recall Rhondium OVC3 One Visit Crown see related information
Date Initiated by Firm January 31, 2019
Create Date December 19, 2019
Recall Status1 Completed
Recall Number Z-0708-2020
Recall Event ID 84126
510(K)Number K143694  
Product Classification Material, tooth shade, resin - Product Code EBF
Product Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand.
Code Information Lot numbers 1832-1099 and 1828-0982.
Recalling Firm/
Manufacturer		 RHONDIUM LIMITED
4 Sheffield Street
Katikati New Zealand
Manufacturer Reason
for Recall		 The product was mislabeled with an incorrect expiration date.
FDA Determined
Cause 2		 Employee error
Action The firm called and emailed their U.S. customers on 1/31/2019 to notify them the device was labeled with the incorrect expiration date and was actually expiring that day.
Quantity in Commerce 6 devices
Distribution Distribution was made to IL, NM, TX, and WI. There was no foreign/military/government distribution.
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.
510(K) Database 510(K)s with Product Code = EBF and Original Applicant = Rhondium, Ltd.
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