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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 Device Recall Fixed Cervical Screwssee related information
Date Initiated by FirmFebruary 20, 2013
Date PostedMarch 08, 2013
Recall Status1 Terminated 3 on September 09, 2013
Recall NumberZ-0921-2013
Recall Event ID 64421
510(K)NumberK111132 
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product3.75mm 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 TX 78746-6446
For Additional Information ContactJoshua 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		Employee error
ActionGenesys 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 Commerce9 cervical screws
DistributionUSA Nationwide Distribution including the states of: CA and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KWQ
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