Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All lot/serial numbers are affected for both Model numbers: 39565 and 39286
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Neuromodulation
- Reason for Recall:
- Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
Product Codes/Lot Numbers:
All lot/serial numbers are affected for both Model numbers: 39565 and 39286
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0859-2016
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