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Completed

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.

FDA Recall Z-0708-2020 · Posted None

Recalling FirmRHONDIUM LIMITED
Recall StatusCompleted
Product CodeEBF
Date Initiated2019-01-31
Product Quantity6 devices

Reason for Recall

The product was mislabeled with an incorrect expiration date.

Firm 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.

Root Cause

Employee error

Distribution Pattern

Distribution was made to IL, NM, TX, and WI. There was no foreign/military/government distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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