Class 2 Device Recall CEZANNE II TLIF BulletTip Cage

• Date Initiated by Firm: August 21, 2019
• Create Date: July 04, 2020
• Recall Status: Completed
• Recall Number: Z-2503-2020
• Recall Event ID: 85218
• 510(K)Number: K131981
• Product Classification: Intervertebral fusion device with bone graft, lumbar - Product Code MAX
• Product: CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.
• Code Information: Lot numbers 14LEDOAB, 15CNDOCC, 15DIDOBC, and 7FGBD.
• Recalling Firm/ Manufacturer: CTL Medical Corporation; 4550 Excel Pkwy Ste 300; Addison TX 75001-5714
• For Additional Information Contact: Mr. Sergiu Vrabie; 214-545-5833
• Manufacturer Reason for Recall: Reports received of the device fracturing during insertion.
• FDA Determined 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: 45 units
• Distribution: Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = MAX and Original Applicant = ACCEL SPINE