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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Event Detail

Event ID 65999
Product Type Devices
Status Completed
Recalling Firm Spine Smith Holdings, LLC
City Austin
State TX
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-31
Initial Firm Notification of
Consignee or Public
Distribution Pattern Distributed in FL.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Part Number: 0301-1410, Lot 53AR Class II The product has the potential to be laser marked as a Medium when it actually is a Small. 32 Z-2258-2013