Date Initiated by Firm |
February 20, 2013 |
Date Posted |
March 08, 2013 |
Recall Status1 |
Terminated 3 on September 09, 2013 |
Recall Number |
Z-0921-2013 |
Recall Event ID |
64421 |
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 TX 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 |
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 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) Database |
510(K)s with Product Code = KWQ and Original Applicant = GENESYS SPINE
|