Recall Z-1823-2015 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
X Spine Systems Inc
Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
| Date | Jun 22, 2015 (initiated Apr 7, 2015) |
| Status | Terminated |
| Reason | The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length. |
| Root cause | Other |
| Action | X-Spine sent an Urgent Medical Device Recall Letter dated April 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: 1. The affected hospital and surgeon should be notified of this recall immediately. 2. Complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately. a. Reference RMA # 5410 b. Use enclosed shipping label 3. No action should be taken with product that has been implanted. Please feel free to |
| Quantity | 75 units |
| Distribution | Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy. |
| 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 |