Rhondium OVC3 One Visit Crown Recalled for Incorrect Expiration Date
Rhondium Limited is recalling six OVC3 One Visit Crown devices because they were mislabeled with an incorrect expiration date.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Rhondium Limited is recalling six units of the Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The devices were distributed to Illinois, New Mexico, Texas, and Wisconsin. There was no foreign, military, or government distribution.
The recall was initiated because the products were mislabeled with an incorrect expiration date. The affected units are identified by lot numbers 1832-1099 and 1828-0982.
Healthcare providers and patients who have these specific devices should contact their healthcare provider or the recalling firm for instructions on how to proceed.
The recalled product
- 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.
- Manufacturer
- RHONDIUM LIMITED
- Category
- Medical Device — Dental Crown
- Hazard
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot numbers 1832-1099 and 1828-0982.
Distribution
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