Driver Instrument recall: Foreign Material
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU…
Why was Driver Instrument recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Driver UDI-DI: 00884662000574, UPN: 102-9800, All Lots. Superion Indirect Decompression System IFU (92479815-02), Superion IDS Kit IFU (92479820-02), Surgical Technique Manual (92479821-02)
- Product
- Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU…
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- Quantity
- 21,533
- Distribution
- US Nationwide Distribution: IN, NY, IL, PA, FL, SC, TX, MA, VA, AL, WI, OK, MO, MI, OH, WV, NC, UT, NH, CA, NJ, TN, NV, AZ, NE, IA, CT, ME, LA, KY, MS, MD, DC, GA, CO, KS, ID, MN, AR, HI, NM, WA, SD, OR, DE, WY, AK, and ND
- Recall date
- June 21, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)