Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

VisuALIF Recalled by Spine Smith Holdings, LLC Due to The product has the potential to be laser...

Date: July 31, 2013
Company: Spine Smith Holdings, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Spine Smith Holdings, LLC directly.

Affected Products

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.

Quantity: 32

Why Was This Recalled?

The product has the potential to be laser marked as a Medium when it actually is a Small.

Where Was This Sold?

This product was distributed to 1 state: FL

Affected (1 state)Not affected

About Spine Smith Holdings, LLC

Spine Smith Holdings, LLC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report