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U.S. Department of Health and Human Services

Class 2 Device Recall CEZANNE II TLIF BulletTip Cage

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 Class 2 Device Recall CEZANNE II TLIF BulletTip Cagesee related information
Date Initiated by FirmAugust 21, 2019
Create DateJuly 04, 2020
Recall Status1 Completed
Recall NumberZ-2502-2020
Recall Event ID 85218
510(K)NumberK131981 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductCEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.
Code Information Lot numbers 14LEDODB, 15CNDOGC, and 15DJDOEC . 
Recalling Firm/
Manufacturer
CTL Medical Corporation
4550 Excel Pkwy Ste 300
Addison TX 75001-5714
For Additional Information ContactMr. Sergiu Vrabie
214-545-5833
Manufacturer Reason
for Recall
Reports received of the device fracturing during insertion.
FDA Determined
Cause 2
Device Design
ActionThe 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 Commerce39 units
DistributionDistribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = MAX
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