Reported Jun 21, 2023 · Ongoing
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect…
Boston Scientific Neuromodulation Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Neuromodulation Corporation · 25155 Rye Canyon Loop · Valencia, CA · 91355-5004
Is this the product you have?
- Driver Instrument, part of the Superion Indirect Decompression System
- REF102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
- Lot codes and dates
- Driver UDI-DI00884662000574
- UPN102-9800, All Lots. Superion Indirect Decompression System IFU (92479815-02), Superion IDS Kit IFU (92479820-02), Surgical Technique Manual (92479821-02)
- Amount recalled
- 21,533
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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