Z-0708-2020Class II

Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label...

Name: 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...
Creator: Rhondium Limited
Published: 2019-01-31
License: https://open.fda.gov/license/

Rhondium Limited / initiated 2019-01-31 / Completed / root cause: manufacturing process

FDA source

RHONDIUM LIMITED began a recall of 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 on 2019-01-31. FDA classified it as Class II and gives the reason as "The product was mislabeled with an incorrect expiration date". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0708-2020
Classification: Class II
Status: Completed
Initiated: 2019-01-31
Posted: 2019-12-19
Recalling firm: Rhondium Limited
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.
Product code: EBF Material, Tooth Shade, Resin
Reason for recall: The product was mislabeled with an incorrect expiration date.
Root cause tag: manufacturing process
FDA 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 in commerce: 6 devices
Distribution: Distribution was made to IL, NM, TX, and WI. There was no foreign/military/government distribution.
Product codes and lots: Lot numbers 1832-1099 and 1828-0982.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0708-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0708-2020	Class II	Completed	Voluntary: Firm initiated	2019-12-25	2019-12-19

Product code EBF

K143694Class IIRhondium One-Visit-Crown(OVC)Rhondium, Ltd. / cleared 2015-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)