Exact FDA event identifier

Event 84126

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: January 31, 2019
Product types: Device
Classifications: Class II
Statuses: Completed
Recalling firm wording: RHONDIUM LIMITED

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0708-2020

Recall number: Z-0708-2020
Initiated: January 31, 2019
Classification: Class II
Status: Completed
Recalling firm: RHONDIUM LIMITED
Quantity: 6 devices

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product was mislabeled with an incorrect expiration date.

Code information

Lot numbers 1832-1099 and 1828-0982.

Distribution pattern

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