Device product
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.
Z-0859-2016
Product summary
- Event
- Event 73139
- Status
- Terminated
- Classification
- Class II
- Quantity
- 51,138 (44,006 US; 9,132 OUS)
- Official record key
device-enforcement:Z-0859-2016
Official wording
Reason: Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.
Code information: All lot/serial numbers are affected for both Model numbers: 39565 and 39286
Distribution pattern: Worldwide Distribution, including US Nationwide.
Derived failure modes
-
Unknown
Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.