Katikati, New Zealand
RHONDIUM LIMITED recalls
1 recall recorded since 2018, most recently on 31 January 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 31 January 2019
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0708-2020
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.