FDAFDA · Food and drugs·Recall number Z-2257-2024
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.
Published July 10, 2024 · Recall initiated: June 3, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nalu Medical, Inc.
- Distributor
- US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.
- Lot
- UDI-DI: 71005-US: 00812537036137, 00812537033600, 00812537033518, 00812537030975, 00812537030524. 71019-US: 00812537036441, 00812537035604, 00812537035598 Serial Numbers: H01377, H01382, H01432, H01419, H01387, H01445, H01415, H01441, H01373, H01428, H01378, H01438, H01431
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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