Recall Z-2123-2020— Boston Scientific Neuromodulation Corporation
Class II · Terminated
Class II FDA medical device recall by Boston Scientific Neuromodulation Corporation, initiated 2019-04-24, terminated 2022-01-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.. Reason: The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue..
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-24
- Terminated
- 2022-01-18
- Firm location
- Valencia, CA, United States
Product description
Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.
Reason for recall
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
Data sourced from openFDA. This site is unofficial and independent of the FDA.