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Spine Smith Holdings, LLC recalls VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis a
Recalled September 25, 2013 · FDA recall Z-2258-2013 · Spine Smith Holdings
Hazard
The product has the potential to be laser marked as a Medium when it actually is a Small. · FDA Class II
Units
32
Sold at
Distributed in FL.
Description
The product has the potential to be laser marked as a Medium when it actually is a Small.
Product
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.
Manufacturer(s)
Spine Smith Holdings, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →