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U.S. Department of Health and Human Services

Class 2 Device Recall Fortex Pedicle Screw System

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 Class 2 Device Recall Fortex Pedicle Screw Systemsee related information
Date Initiated by FirmApril 12, 2017
Date PostedApril 27, 2017
Recall Status1 Terminated 3 on August 16, 2017
Recall NumberZ-1884-2017
Recall Event ID 76842
510(K)NumberK120832 
Product Classification Orthosis, spondylolisthesis spinal fixation - Product Code MNH
Product5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected between two or more pedicle screws to create a pedicle screw construct. Indications for Use: The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Code Information Part number X077-0420, lot number 041218
Recalling Firm/
Manufacturer		 XTANT MEDICAL INC
664 Cruiser Ln
Belgrade MT 59714-9719
Manufacturer Reason
for Recall		The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium.
FDA Determined
Cause 2		Labeling mix-ups
ActionXTANT sent an Urgent Medical Device Removal letter dated 4/12/2017 to customers with a Return Response Acknowledgement and Receipt form. The letter identified the affected product, problem and actions to be taken. For questions call 406-570-7028.
Quantity in Commerce97 units
DistributionWorldwide distribution - US Nationwide in the states of: AZ, CA, CT, GA, LA, NV, OH, TX and in the country of Mexico.
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 = MNH
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