Recall Z-2121-2020 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Boston Scientific Neuromodulation Corporation
LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation. Package Contents Percutaneous Permanent Lead Kits (1) Percutaneous Lead with pre-loaded Curve
| Date | Apr 24, 2019 |
| Status | Terminated |
| 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 the "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. |
| Root 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 pro |
| Quantity | 3 units |
| Distribution | Distributed OUS only. to 14 countries. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.