Medical device recalls Moderate risk

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

Recall date
August 21, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2501-2020
FDA classification
Class II
Brand / firm
CTL Medical Corporation
Sold / distributed
Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.

Why it was recalled

Reports received of the device fracturing during insertion.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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