Exact FDA event identifier

Event 81935

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

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Event summary

Timeline bucket: January 09, 2018
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Riverpoint Medical, LLC

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

RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. The Riverpoint Brachytherapy Grid is placed against the skin of the patient to help the user place the needles in a grid pattern. The letters and numbers can also correspond with computerized grids to aid in placement.

Z-0777-2019

Recall number: Z-0777-2019
Initiated: January 09, 2018
Classification: Class III
Status: Terminated
Recalling firm: Riverpoint Medical, LLC
Quantity: 443 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product is labeled with "CE", but is not yet approved in the European Union.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product is labeled with "CE", but is not yet approved in the European Union.

Code information

Lot Numbers: 18061816, 18101521

Distribution pattern

US Nationwide Distribution in the states of IL, WA, and FL