VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.

Class I - Dangerous

🏥 Medical Devices Recalled: July 31, 2013 Spine Smith Holdings Implants & Prosthetics

What Should You Do?

Check if you have this product:
Part Number: 0301-1410, Lot 53AR
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Spine Smith Holdings, LLC
Reason for Recall:: The product has the potential to be laser marked as a Medium when it actually is a Small.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.

Product Codes/Lot Numbers:

Part Number: 0301-1410, Lot 53AR

Distribution:

Distributed in: FL

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2258-2013