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.
Reported: March 2, 2016 Initiated: January 11, 2016 #Z-0859-2016
Product 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.
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.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 51,138 (44,006 US; 9,132 OUS)
- Distribution
- Worldwide Distribution, including US Nationwide.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Neuromodulation. Units affected: 51,138 (44,006 US; 9,132 OUS).
Why was this product recalled? ▼
Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 2, 2016. Severity: Moderate. Recall number: Z-0859-2016.
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