Recall Z-1972-2023— Boston Scientific Neuromodulation Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Neuromodulation Corporation, initiated 2023-05-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual. Reason: Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury..
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-12
- Firm location
- Valencia, CA, United States
Product description
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
Reason for recall
Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.