FDA recall Z-0708-2020

RHONDIUM LIMITED · Class II · device

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

Status
Completed
Initiation date
2019-01-31
Report date
2019-12-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Katikati, New Zealand

Primary source

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