FDAFDA · Food and drugs·Recall number Z-2120-2020
Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. 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 Product Usage: Contact extension kits are part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. They are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation.
Published June 3, 2020 · Recall initiated: April 24, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Distributor
- Distributed OUS only. to 14 countries.
- Lot
- Part number M365SC3138350; serial numbers 1041034, 1055172, 3000549, 1041380, 1056806, 3000564, 1053375, 1058008, 3001907, 1053695, 1058015, 3007457, 1053700, 1058017, 3008119, 1054299, 1062660, 1054304, and 1064590.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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