|
Class 2 Device Recall CEZANNE II TLIF BulletTip Cage |
|
Date Initiated by Firm |
August 21, 2019 |
Create Date |
July 04, 2020 |
Recall Status1 |
Completed |
Recall Number |
Z-2504-2020 |
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 L30, H8mm, Part #018.1908. |
Code Information |
Lot numbers 14LEDOEB, 15CNDOHC, and 15DJDOHC. |
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 2 |
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. |
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
|
|
|
|