FDAClass IIJuly 15, 2020

CEZANNE II TLIF Bullet-Tip Cage recall

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

Why was CEZANNE II TLIF Bullet-Tip Cage recalled?

Reports received of the device fracturing during insertion.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers 14LDDOCB, 15CNDOBC, 15DIDOCC, and 7FGAD.

Product
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.
Recalling firm
CTL Medical Corporation
Quantity
39 units
Distribution
Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.
Recall date
July 15, 2020
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls