Z-0217-2024 Class II
Recall Details
- Product Type
- Devices
- Report Date
- November 8, 2023
- Initiation Date
- May 27, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
Product Description
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Reason for Recall
There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.
Distribution Pattern
US: MO, FL, TX, WA
Code Information
UDI/DI 00763000274320, Serial Number VA2JV2V