FDA-Device2013-09-25Class II
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.
Spine Smith Holdings, LLC
Hazard
The product has the potential to be laser marked as a Medium when it actually is a Small.
Sold states
Distributed in FL.
Affected count
32
Manufactured in
93 Red River St, N/A, Austin, TX, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2258-2013Don't want to check this manually?
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