Z-0708-2020 Class II
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2019
- Initiation Date
- January 31, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 devices
Product Description
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 Pattern
Distribution was made to IL, NM, TX, and WI. There was no foreign/military/government distribution.
Code Information
Lot numbers 1832-1099 and 1828-0982.