Recall Z-1512-2015— X Spine Systems Inc

Name: FDA recall Z-1512-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-11

Class II · Terminated

Class II FDA medical device recall by X Spine Systems Inc, initiated 2015-03-11, terminated 2015-10-21. It names one FDA 510(k) clearance: K120832. Product: 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.. 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..

Recalling firm: X Spine Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2015-03-11
Terminated: 2015-10-21
Firm location: Miamisburg, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K120832 — FORTEX PEDICLE SCREW SYSTEMX-Spine Systems, Inc.·cleared 2012-10-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.