Boston Scientific has recalled approximately 70,516 Superion Indirect Decompression System (IDS) Kits and associated implants due to reports that the devices and instruments are not consistently meeting performance levels and may break. The breakage can affect both the specialized single-use instruments used during surgery and the permanent spinal implants themselves. This voluntary recall affects various sizes of the Superion VF Implant and the Vertiflex Procedure Instrument Platform. Healthcare facilities and surgical centers should stop using the affected products and contact the manufacturer to arrange for their return or replacement.
Breakage of surgical instruments or spinal implants during or after a medical procedure can lead to serious surgical complications, including the failure to treat the underlying condition or the need for additional surgery to remove broken fragments or replace a failed device.
Healthcare facility correction and return
Part of the Superion IDS Kit
Part of the Superion IDS Kit
Part of the Superion IDS Kit
Part of the Superion IDS Kit
Part of the Superion IDS Kit
Single-use disposable instrument set for delivering the Superion Implant.
Instrument platform for the Vertiflex Procedure.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.