Specify 5-6-5 Lead recall: Labeling Error
Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating…
Why was Specify 5-6-5 Lead recalled?
Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lot/serial numbers are affected for both Model numbers: 39565 and 39286
- Product
- Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating…
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 51,138 (44,006 US; 9,132 OUS)
- Distribution
- Worldwide Distribution, including US Nationwide.
- Recall date
- March 2, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)