Recall Z-1884-2017 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
XTANT MEDICAL INC
5.5mm 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
| Date | Apr 27, 2017 (initiated Apr 12, 2017) |
| Status | Terminated |
| Reason | The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium. |
| Root cause | Labeling mix-ups |
| Action | XTANT 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 | 97 units |
| Distribution | Worldwide distribution - US Nationwide in the states of: AZ, CA, CT, GA, LA, NV, OH, TX and in the country of Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120832 | FORTEX PEDICLE SCREW SYSTEM X-Spine Systems, Inc., Oct 23, 2012 |