Z-3161-2024 Class III Ongoing

Recalled by Carbon Medical Technologies, Inc. — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
September 25, 2024
Initiation Date
July 26, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25 boxes of 3 devices

Product Description

BiomarC EX Fiducial Marker System, Catalog Number 040165

Reason for Recall

This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.

Distribution Pattern

US Nationwide distribution in the state of TN.

Code Information

UDI/DI 00850002461305, Lot Number 2112355B