Superion Indirect Decompression System spinal implants recalled for device breakage
Boston Scientific recalls Superion Indirect Decompression System spinal implants due to device and instrument breakage affecting performance.
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: This is an FDA Class II medical device recall without reported illnesses, injuries, or deaths. The recall involves actual performance failures (instrument and implant breakage) rather than theoretical hazards, placing it in the 'High' category as a risk-of-harm medical device where no injury has yet been reported.
Plain-English summary
Boston Scientific Neuromodulation Corporation is recalling the Superion Indirect Decompression System (Superion IDS Kit). The recalled products include multiple implant sizes (8mm, 10mm, 12mm, 14mm, and 16mm) along with associated surgical instruments and the Vertiflex Procedure Instrument Platform. The recall affects approximately 70,516 units that have been distributed nationwide to all U.S. states.
The recall was initiated as a result of a comprehensive product performance review. The review determined that the devices and instruments are not consistently meeting expected performance levels. Specific issues identified include breakage of the instruments and implants.
Patients and healthcare providers with affected units should contact Boston Scientific Neuromodulation Corporation for information regarding affected lot numbers and guidance on next steps.
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
- Category
- Medical Device — Spinal Implant
- Hazard
- breakage
- device-failure
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.
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