Recall Z-0708-2020— RHONDIUM LIMITED
Class II · Completed
Class II FDA medical device recall by RHONDIUM LIMITED, initiated 2019-01-31. It names one FDA 510(k) clearance: K143694. 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.. Reason: The product was mislabeled with an incorrect expiration date..
- Recalling firm
- RHONDIUM LIMITED
- Classification
- Class II
- Status
- Completed
- Initiated
- 2019-01-31
- Firm location
- Katikati, New Zealand
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.