# FDA recall Z-0708-2020

> **RHONDIUM LIMITED** · Class II · device recall initiated 2019-01-31.

## 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.

## Distribution

Distribution was made to IL, NM, TX, and WI.  There was no foreign/military/government distribution.

## Key facts

- **Recall number:** Z-0708-2020
- **Recalling firm:** RHONDIUM LIMITED
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2019-01-31
- **Report date:** 2019-12-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Katikati, New Zealand

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0708-2020

## Citation

> AI Analytics. FDA recall Z-0708-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0708-2020. Source: US FDA. Licensed CC0.

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