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
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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)
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = NKB
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