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U.S. Department of Health and Human Services

Class 2 Device Recall Fixed Cervical Screws

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 Class 2 Recall
Fixed Cervical Screws
see related information
Date Posted March 08, 2013
Recall Status1 Terminated on September 09, 2013
Recall Number Z-0921-2013
Recall Event ID 64421
Premarket Notification
510(K) Number
K111132 
Product Classification Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
Product 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.
Code Information Part Number: GCSF37512 and Lot Number: 0243
Recalling Firm/
Manufacturer
Genesys Orthopedic Systems, LLC
1250 S Capital Of Texas Hwy
Bldg #3, Suite 600
Austin, Texas 78746-6446
For Additional Information Contact Joshua Kaufman
512-381-7070
Manufacturer 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.
FDA Determined
Cause 2
TRAINING: Employee Error
Action Genesys Orthopedic Systems, LLC sent a Recall Notification letter dated February 20, 2013 to all affected customers. The letter identified the affected product, problem and necessary actions to be taken. Customers were instructed to immediately return the affected product to the Genesys Spine office and complete and return the enclosed Response Form as soon as possible. For questions call 512-381-7070.
Quantity in Commerce 9 cervical screws
Distribution USA Nationwide Distribution including the states of: CA and TX.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KWQ and Original Applicant = GENESYS SPINE
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