FDAFDA · Food and drugs·Recall number Z-2258-2013
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.
Published September 25, 2013 · Recall initiated: July 31, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The product has the potential to be laser marked as a Medium when it actually is a Small.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Spine Smith Holdings, LLC
- Distributor
- Distributed in FL.
- Lot
- Part Number: 0301-1410, Lot 53AR
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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