Z-0859-2016 Class II Terminated
FDA device recall Z-0859-2016 was initiated by Medtronic Neuromodulation on Jan 11, 2016 and is designated Class II. 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. The recall status is terminated (terminated Jan 20, 2017). Affected quantity: 51,138 (44,006 US; 9,132 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Mar 2, 2016
- Initiation Date
- Jan 11, 2016
- Termination Date
- Jan 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51,138 (44,006 US; 9,132 OUS)
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.
Distribution Pattern
Worldwide Distribution, including US Nationwide.
Code Information
All lot/serial numbers are affected for both Model numbers: 39565 and 39286
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0859-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026