FDA-Device2020-07-15Class II

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.

CTL Medical Corporation
Hazard

Reports received of the device fracturing during insertion.

Sold states
Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.
Affected count
45 units
Manufactured in
4550 Excel Pkwy Ste 300, Addison, TX, United States
Products
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2503-2020

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