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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 Crownsee related information
Date Initiated by FirmJanuary 31, 2019
Create DateDecember 19, 2019
Recall Status1 Completed
Recall NumberZ-0708-2020
Recall Event ID 84126
510(K)NumberK143694 
Product Classification Material, tooth shade, resin - Product Code EBF
ProductRhondium 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
ActionThe 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 Commerce6 devices
DistributionDistribution was made to IL, NM, TX, and WI. There was no foreign/military/government distribution.
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.
510(K) Database510(K)s with Product Code = EBF
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