Z-0777-2019 Class III Terminated
FDA device recall Z-0777-2019 was initiated by Riverpoint Medical, LLC on Jan 9, 2018 and is designated Class III. Reason for recall: Product is labeled with "CE", but is not yet approved in the European Union. The recall status is terminated (terminated Apr 15, 2019). Affected quantity: 443 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 6, 2019
- Initiation Date
- Jan 9, 2018
- Termination Date
- Apr 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 443 devices
Product Description
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 Pattern
US Nationwide Distribution in the states of IL, WA, and FL
Code Information
Lot Numbers: 18061816, 18101521
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0777-2019
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026