Z-2504-2020Class II

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

Name: Z-2504-2020 CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908
Creator: CTL Medical Corporation
Published: 2019-08-21
License: https://open.fda.gov/license/

CTL Medical Corporation / initiated 2019-08-21 / Completed / root cause: design

FDA source

CTL Medical Corporation began a recall of CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908 on 2019-08-21. FDA classified it as Class II and gives the reason as "Reports received of the device fracturing during insertion". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-2504-2020
Classification: Class II
Status: Completed
Initiated: 2019-08-21
Posted: 2020-07-04
Recalling firm: CTL Medical Corporation
Product: CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Reports received of the device fracturing during insertion.
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm issued letters dated 8/21/2019 to all distributors or CTL representatives via email beginning 8/21/2019 with a follow-up hard copy of the correspondence being issued via FedEx. The devices were to be returned.
Quantity in commerce: 46 units
Distribution: Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.
Product codes and lots: Lot numbers 14LEDOEB, 15CNDOHC, and 15DJDOHC.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2504-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2501-2020	Class II	Completed	Voluntary: Firm initiated	2020-07-15	2020-07-04
Z-2502-2020	Class II	Completed	Voluntary: Firm initiated	2020-07-15	2020-07-04
Z-2503-2020	Class II	Completed	Voluntary: Firm initiated	2020-07-15	2020-07-04
Z-2504-2020	Class II	Completed	Voluntary: Firm initiated	2020-07-15	2020-07-04

Product code MAX

K131981Class IICezanne II Interbody Fusion SystemAccel Spine / cleared 2013-10-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)