Z-2119-2020 Class II Terminated
FDA device recall Z-2119-2020 was initiated by Boston Scientific Neuromodulation Corporation on April 24, 2019 and is designated Class II. 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 the "use by date" displayed on the la… The recall status is terminated (terminated January 18, 2022). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- April 24, 2019
- Termination Date
- January 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registration Form/Temporary Patient Identification Card; (1) Manual - Product Usage: The surgical paddle leads function as a component of Boston Scientific s spinal cord stimulator (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in a inhibition of pain sensation.
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 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.
Distribution Pattern
Distributed OUS only. to 14 countries.
Code Information
Part number M365SC8216700; serial numbers 632107 and 645608