Reported Sep 25, 2013 · Terminated

VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis…

Spine Smith Holdings, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Spine Smith Holdings, LLC · 93 Red River St · Austin, TX · 78701-4216

Is this the product you have?

  • VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles
  • part number0301-1410. Intended to be implanted via an open anterior approach
Lot codes and dates
  • Part Number
    • 0301-1410
    • Lot 53AR
Amount recalled
32

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Spine Smith Holdings, LLC recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 18, 2014 · Data as of Sep 19, 6:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.