Reported Mar 2, 2016 · Terminated
Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a…
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
Specify 5-6-5 LeadSpecify 2x8 Lead
- Model Numbers39565, 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
- Lot codes and dates
- All lot/serial numbers
- are affected for both Model numbers39565 and 39286
- Amount recalled
- 51,138 (44,006 US; 9,132 OUS)
Where it was sold
- Nationwide
Why it was recalled
Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.
This product could cause temporary or reversible health problems — stop using it.
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