Z-2672-2020Class II

ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM

Name: Z-2672-2020 ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
Creator: U&i Corp.
Published: 2020-05-26
License: https://open.fda.gov/license/

CG MedTech Co., Ltd. / initiated 2020-05-26 / Terminated / root cause: manufacturing process

FDA source

U&I CORP. began a recall of ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM on 2020-05-26. FDA classified it as Class II and gives the reason as "6.0x50mm poly-reduction screws were laser etched 6.0x45". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2672-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-26
Posted: 2020-07-20
Terminated: 2024-04-05
Recalling firm: CG MedTech Co., Ltd.
Product: ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: 6.0x50mm poly-reduction screws were laser etched 6.0x45
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: Lot #: 19C12063

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2672-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2672-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-20

Product code NKB

K173524Class IIANAX 5.5™ Spinal SystemU&I Corporation / cleared 2017-12-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)