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.
Z-0708-2020
Product summary
- Firm
- RHONDIUM LIMITED
- Event
- Event 84126
- Status
- Completed
- Classification
- Class II
- Quantity
- 6 devices
- Official record key
device-enforcement:Z-0708-2020
Official wording
Reason: The product was mislabeled with an incorrect expiration date.
Code information: Lot numbers 1832-1099 and 1828-0982.
Distribution pattern: Distribution was made to IL, NM, TX, and WI. There was no foreign/military/government distribution.
Derived failure modes
-
Labeling or packaging
mislabeled