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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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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
Distribution Pattern USA Nationwide Distribution including the states of: CA and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Part Number: GCSF37512 and Lot Number: 0243 Class II 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. 9 cervical screws Z-0921-2013