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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Detail

Product Description 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
Recall Number Z-0921-2013
Classification Class II
Code Info Part Number: GCSF37512 and Lot Number: 0243
Product Distributed Qty 9 cervical screws
Reason For Recall Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.

Event Detail

Event Id 64421
Product Type Devices
Status Ongoing
Recalling Firm Genesys Orthopedic Systems, LLC
City Austin
State TX
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide Distribution including the states of: CA and TX.
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