Recall Z-0708-2020 ยท EBF Material, Tooth Shade, Resin
RHONDIUM LIMITED
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.
| Date | Jan 31, 2019 |
| Status | Completed |
| Reason | The product was mislabeled with an incorrect expiration date. |
| Root cause | Employee error |
| Action | The firm called and emailed their U.S. customers on 1/31/2019 to notify them the device was labeled with the incorrect expiration date and was actually expiring that day. |
| Quantity | 6 devices |
| Distribution | Distribution was made to IL, NM, TX, and WI. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143694 | Rhondium One-Visit-Crown(OVC) Rhondium, Ltd., May 15, 2015 |