Recall Z-2485-2025 ยท NQO Prosthesis, Spinous Process Spacer/Plate
Boston Scientific Neuromodulation Corporation
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 Superion Indirect Decompression System 14MM, VF Implant 101-9814 00884662000550 Superion Indirect Decompression System 16MM, VF Implant 101-
| Date | Sep 2, 2025 (initiated Jun 6, 2025) |
| Status | Open, Classified |
| Reason | As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device. |
| Root cause | Device Design |
| Action | On 06/06/2025, the firm sent an "Urgent Medical Device Removal - Immediate Action Required" Letter to customers inform them that, as a result of a comprehensive performance review of the Superion system and have determined that it is not meeting expected performance levels during the implantation procedure which includes breakage of the instrument (e.g., driver tip and insertion tool) and the device (e.g., spindle cap). Customer are instructed to: Physicians should stop all implants of the Superion Indirect Decompression System. Further distribution or use of any remaining affected product sh |
| Quantity | 70,516 |
| Distribution | U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.