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
0301-1410Lot 53AR
- Part Number
- 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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