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.
Recall
- Recall Number
- Z-2123-2020
- Event Number
- 84983
- Firm
- Boston Scientific Neuromodulation Corporation
- FEI Number
- 3006630150
- Product Code
- LGW
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- April 24, 2019
- Terminated
- January 18, 2022
- Address
- 25155 Rye Canyon Loop, Valencia, CA, 91355-5004
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.
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.
Customers to the user level are being notified of the recall via letter sent by DHL courier beginning on April 24, 2019. A third-party recalling company is not being used. The Urgent Medical Device Product Removal Letter instructs customers to immediately cease further distribution or use of any remaining product affected by this removal. Customers who identify any affected products within their inventory are instructed to segregate them immediately and return the product(s) to the recalling firm in accordance with enclosed instructions. Customers will receive replacements for all removed products returned to the manufacturer. Customers who are distributors are requested to notify any of their customers who have received the affected product(s). Recipients of the recall notice are requested to pass the notice to any healthcare professional from their organization who needs to be aware and to any organization where the potentially affected devices have been transferred, if appropriate. In addition, it is requested that customers provide the recalling firm with details of any affected devices that have been transferred to other organizations. Customers are requested to email or fax the Reply Verification Tracking Form to the BSC Field Action Center to [email protected] or by fax to 1-866-213-1806. Return of the RVTF is requested even if customers do not have any affected product to return.
Distributed OUS only. to 14 countries.
2 units