Z-0777-2019Class III

RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18

Name: Z-0777-2019 RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18
Creator: Riverpoint Medical, LLC
Published: 2018-01-09
License: https://open.fda.gov/license/

Riverpoint Medical, LLC / initiated 2018-01-09 / Terminated / root cause: labeling and UDI

FDA source

Riverpoint Medical, LLC began a recall of 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... on 2018-01-09. FDA classified it as Class III and gives the reason as "Product is labeled with "CE", but is not yet approved in the European Union". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0777-2019
Classification: Class III
Status: Terminated
Initiated: 2018-01-09
Posted: 2019-01-28
Terminated: 2019-04-15
Recalling firm: Riverpoint Medical, LLC
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.
Product code: IWJ System, Applicator, Radionuclide, Manual
Reason for recall: Product is labeled with "CE", but is not yet approved in the European Union.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm initiated the recall by telephone following with an email and letter on 01/09/02019 The firm requested the return of the recalled product.
Quantity in commerce: 443 devices
Distribution: US Nationwide Distribution in the states of IL, WA, and FL
Product codes and lots: Lot Numbers: 18061816, 18101521

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0777-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0777-2019	Class III	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-28

Product code IWJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)