Class II — RHONDIUM LIMITED
| Recalling firm | RHONDIUM LIMITED |
|---|---|
| Registered facility | RHONDIUM LIMITED (the firm's only registered facility) |
| Classification | Class II |
| Status | Completed |
| Reason | The product was mislabeled with an incorrect expiration date. |
| 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. |
| Quantity | 6 devices |
| Distribution | Distribution was made to IL, NM, TX, and WI. There was no foreign/military/government distribution. |
| Initiated | 2019-01-31 |
| Classified | 2019-12-19 |
| Recall number | Z-0708-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — RHONDIUM LIMITED (Z-0708-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84126/
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