Recall Z-2501-2020— CTL Medical Corporation

Name: FDA recall Z-2501-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-21

Class II · Completed

Class II FDA medical device recall by CTL Medical Corporation, initiated 2019-08-21. It names one FDA 510(k) clearance: K131981. Product: CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.. Reason: Reports received of the device fracturing during insertion..

Recalling firm: CTL Medical Corporation
Classification: Class II
Status: Completed
Initiated: 2019-08-21
Firm location: Addison, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K131981 — CEZANNE II INTERBODY FUSION SYSTEMAccel Spine·cleared 2013-10-09

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

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.

Reason for recall

Reports received of the device fracturing during insertion.

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