PlainRecalls
FDA Devices Moderate Class II Completed

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.

Reported: July 15, 2020 Initiated: August 21, 2019 #Z-2502-2020

Product Description

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.

Reason for Recall

Reports received of the device fracturing during insertion.

Details

Recalling Firm
CTL Medical Corporation
Units Affected
39 units
Distribution
Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.
Location
Addison, TX

Frequently Asked Questions

What product was recalled?
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.. Recalled by CTL Medical Corporation. Units affected: 39 units.
Why was this product recalled?
Reports received of the device fracturing during insertion.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 15, 2020. Severity: Moderate. Recall number: Z-2502-2020.