Recall Z-1823-2015— X Spine Systems Inc

Name: FDA recall Z-1823-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-07

Class II · Terminated

Class II FDA medical device recall by X Spine Systems Inc, initiated 2015-04-07, terminated 2015-10-01. It names one FDA 510(k) clearance: K120832. Product: Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400. Reason: The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length..

Recalling firm: X Spine Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2015-04-07
Terminated: 2015-10-01
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

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

Reason for recall

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

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