Z-0537-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 9, 2022
- Initiation Date
- December 9, 2021
- Termination Date
- September 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2720 units
Product Description
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
Reason for Recall
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Distribution Pattern
US Nationwide distribution.
Code Information
All lots UDI: 03664539000077