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U.S. Department of Health and Human Services

Class 2 Device Recall The ANAX 5.5 SPINAL SYSTEM

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  Class 2 Device Recall The ANAX 5.5 SPINAL SYSTEM see related information
Date Initiated by Firm May 26, 2020
Create Date July 20, 2020
Recall Status1 Terminated 3 on April 05, 2024
Recall Number Z-2672-2020
Recall Event ID 85841
510(K)Number K173524  
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
Product ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
Code Information Lot #: 19C12063
Recalling Firm/
Manufacturer		 U&I CORP.
20 Sandan-Ro 76 Beon-Gil
Uijeongbu Korea (the Republic of)
Manufacturer Reason
for Recall		 6.0x50mm poly-reduction screws were laser etched 6.0x45
FDA Determined
Cause 2		 Process control
Action On 05/26/20, a Request to Return Products Which Have Laser Marking Issue notice was sent to the firm customer. The customer was first asked to distinguish and isolate affected product and then to return affected product. This customer/distributor sent Notification for Sales Suspension and Product Recall notices to their customers. Customers were asked to return affected product and to fill out and return the Notification for Sales Suspension and Product Recall notices to acknowledge receipt.
Quantity in Commerce 6
Distribution U.S.: AZ
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 = NKB and Original Applicant = U&I Corporation
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