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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

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

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 Other
Distribution Pattern Distributed in FL.
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