Data Foundry

Medical device recalls 2019

Rhondium OVC3 One Visit Crown — Class II medical device recall Z-0708-2020

Completed recall by RHONDIUM LIMITED, reported 2019-12-25, distributed in IL, NM, TX, WI. The product was mislabeled with an incorrect expiration date.

Recall numberZ-0708-2020
Product typeMedical device
ClassificationClass II
StatusCompleted
Voluntary or mandatedVoluntary
Recalling firmRHONDIUM LIMITED, Katikati, New Zealand
Recall initiated2019-01-31
Classified2019-12-19
Reported by FDA2019-12-25
DistributedIL, NM, TX, WI
Quantity6 devices
Reason classeslabeling
Lot numbers1828-0982, 1832-1099
Model numbers12/13L, 24/25LUSA

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.

Reason for recall

The product was mislabeled with an incorrect expiration date.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0708-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.