X Spine Systems Inc: Medical Device Recall in 2015 - (Recall #: Z-1512-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 11, 2015

Date Posted: April 29, 2015

Recall Number: Z-1512-2015

Event ID: 70774

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.

Status: Terminated

Product Quantity: 14 units

Code Information:

Lot #: 4084-01; M/N X073-5555; UDI: *+M697X07355551/$408401U*

Distribution Pattern:

US Distribution to states of: KS, NV & TX.

Voluntary or Mandated:

Voluntary: Firm initiated