Recall Z-1512-2015 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
X Spine Systems Inc
Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
| Date | Apr 22, 2015 (initiated Mar 11, 2015) |
| Status | Terminated |
| Reason | One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, X-spine Systems, Inc., sent an "Urgent Medical Device Recall" letter dated March 19, 2015 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to notify affected hospital and surgeon of the recall immediately; complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately via mail: 725 Alexandersville Road, Miamisburg OH 45342-RMA #5288; and No action should be taken with product that has been implanted. Please contact customer servic |
| Quantity | 14 units |
| Distribution | US Distribution to states of: KS, NV & TX. |
| 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 |