Z-2124-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- April 24, 2019
- Termination Date
- January 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 units
Product Description
Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the lead for a trial procedure or to extend the lead when a permanent IPG is implanted. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual
Reason for Recall
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
Distribution Pattern
Distributed OUS only. to 14 countries.
Code Information
Part number M365SC3138550; serial numbers 1044463, 1066242, 3003060, 1044464, 1068589, 3006620, 1044466, 1068602, 3009041, 1061554, 1068606, 3009045, 1062766, 1068608, 3009050, 1062770, 1068611, 3010114, 1062787, 3001046, 3012781, 1063430, 3002547, 3013204, 1063632, 3002561, 3013267, 1063650, 3002817, 3018105, 1063749, 3003040, 3018106, 1063798, 3003042, 3018866, 1063801, 3003047, 3036973, 1066182, and 3003048.