# FDA recall Z-0777-2019

> **Riverpoint Medical, LLC** · Class III · device recall initiated 2018-01-09.

## Product

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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-0777-2019
- **Recalling firm:** Riverpoint Medical, LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-09
- **Report date:** 2019-02-06
- **Termination date:** 2019-04-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portland, OR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0777-2019

## Citation

> AI Analytics. FDA recall Z-0777-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0777-2019. Source: US FDA. Licensed CC0.

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