X Spine Systems Inc: Medical Device Recall in 2015 - (Recall #: Z-1823-2015)

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:

Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400

Product Classification:

Class II

Date Initiated: April 7, 2015

Date Posted: July 1, 2015

Recall Number: Z-1823-2015

Event ID: 71357

Reason for Recall:

The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.

Status: Terminated

Product Quantity: 75 units

Code Information:

Model #: N60001068; Lot #: 2943-01; Serial #s: 46118, 46581, 47296, 47588, 47653, 48164, 48201, 48412, 49156, 49585, 49586, 49649, G22, G45, G47, G77, G83, G87X, G90X, R15, XP03, XP21, XP27, XP28, XP29 & XP32.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated