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U.S. Department of Health and Human Services

Class 2 Device Recall Velofix SA cervical cage

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  Class 2 Device Recall Velofix SA cervical cage see related information
Date Initiated by Firm January 30, 2019
Create Date April 29, 2020
Recall Status1 Terminated 3 on November 20, 2020
Recall Number Z-1823-2020
Recall Event ID 84989
510(K)Number K172424  
Product Classification Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
Product Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.
Code Information Lots: A18K220, A18L065, A18L013, A18L014, A18L015, A18L018, A18L019, A18L020, A18L021    
Recalling Firm/
Manufacturer		 U&I CORP.
20 Sandan-Ro 76 Beon-Gil
Uijeongbu-Si Gyeonggi-Do Korea (the Republic of)
Manufacturer Reason
for Recall		 The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability, or less bone-screw engagement than intended by physicians.
FDA Determined
Cause 2		 Employee error
Action On 01/30/2019, "Notification for Sales Suspension and Product recall" and explanation of nonconformity notices were emailed to the domestic customer. The notification requests customers identify, isolate and return affected products immediately. It requests acknowledgement, and quantity of devices to be returned. The contact number for further questions is +82 31 860-6830 or kkjane@youic.com
Quantity in Commerce 42
Distribution US Nationwide distribution in the state of CA.
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OVE and Original Applicant = U&I Corporation
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