FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0708-2020
- 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.
- Status
- Completed
- Initiated
- 2019-01-31
- Posted
- not on file
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- Lot numbers 1832-1099 and 1828-0982.
- 510(k) numbers
- ["K143694"]
- PMA numbers
- not on file
- Product code
- EBF
- Firm FEI
- 3011789026
- Firm city
- Katikati
- Firm state
- not on file
- Firm country
- New Zealand
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28