Recall Z-0126-2017— X Spine Systems Inc

Name: FDA recall Z-0126-2017
Creator: U.S. Food and Drug Administration
Published: 2016-05-17

Class II · Terminated

Class II FDA medical device recall by X Spine Systems Inc, initiated 2016-05-17, terminated 2019-04-04. It names one FDA 510(k) clearance: K131350. Product: Calix T PEEK Lumbar System, TLIF Rasp. Reason: The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space..

Recalling firm: X Spine Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2016-05-17
Terminated: 2019-04-04
Firm location: Miamisburg, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K131350 — CALIX LUMBAR SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.·cleared 2013-10-23

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

Calix T PEEK Lumbar System, TLIF Rasp

Reason for recall

The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.

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