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Recall Observatory FDA recall evidence

Device product

CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.

Z-2504-2020

August 21, 2019

Class II

Product summary

Firm
CTL Medical Corporation
Event
Event 85218
Status
Completed
Classification
Class II
Quantity
46 units
Official record key
device-enforcement:Z-2504-2020

Official wording

Reason: Reports received of the device fracturing during insertion.

Code information: Lot numbers 14LEDOEB, 15CNDOHC, and 15DJDOHC.

Distribution pattern: Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Reports received of the device fracturing during insertion.