Spinal decompression implants recalled after review found instrument and device breakage
Superion Indirect Decompression System implants and kits are recalled because a product performance review found the device and instruments are not consistently meeting expected performance, including breakage. 70,516 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; breakage of a spinal implant or its instruments is a potential harm and no injuries are reported.
Plain-English summary
The Superion IDS Kit and Superion Indirect Decompression System VF implants in 8 mm, 10 mm, 12 mm and further sizes, under catalog numbers including 101-9808, 101-9810 and 101-9812, are being recalled across all lot and batch numbers. The recall covers 70,516 units distributed nationwide in the United States.
As a result of a comprehensive product performance review, the manufacturer determined that the device and instruments are not consistently meeting expected performance levels. The issues include breakage of the instruments and of the implant or device. The FDA classified the action as Class II.
Hospitals and surgical centres holding affected stock should quarantine it and follow the manufacturer's instructions for return. Patients with an implanted device who have questions should speak to their surgeon.
The recalled product
- Product
- 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
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Hazard
- device-breakage
- performance-failure
- spinal-implant
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Superion Indirect Decompression System 8MM
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22