Class 2 Device Recall PrecisionTM

• Date Initiated by Firm: April 24, 2019
• Create Date: May 26, 2020
• Recall Status: Terminated on January 18, 2022
• Recall Number: Z-2123-2020
• Recall Event ID: 84983
• PMA Number: P030017
• Product Classification: Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
• 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.
• Code Information: Part number M365SC9218150; serial numbers 1043743 and 1051329.
• Recalling Firm/ Manufacturer: Boston Scientific Neuromodulation Corporation; 25155 Rye Canyon Loop; Valencia CA 91355-5004
• For Additional Information Contact: Nicole Pshon; 661-949-4000
• Manufacturer 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.
• FDA Determined Cause: Labeling Change Control
• Action: 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 BCSFieldActionCenter@bsci.com 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.
• Quantity in Commerce: 2 units
• Distribution: Distributed OUS only. to 14 countries.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LGW