Z-1823-2020Class II

Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409...

Name: Z-1823-2020 Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409...
Creator: U&i Corp.
Published: 2019-01-30
License: https://open.fda.gov/license/

CG MedTech Co., Ltd. / initiated 2019-01-30 / Terminated / root cause: manufacturing process

FDA source

U&I CORP. began a recall of Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated... on 2019-01-30. FDA classified it as Class II and gives the reason as "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...". 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-1823-2020
Classification: Class II
Status: Terminated
Initiated: 2019-01-30
Posted: 2020-04-29
Terminated: 2020-11-20
Recalling firm: CG MedTech Co., Ltd.
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.
Product code: OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
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.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]
Quantity in commerce: 42
Distribution: US Nationwide distribution in the state of CA.
Product codes and lots: Lots: A18K220, A18L065, A18L013, A18L014, A18L015, A18L018, A18L019, A18L020, A18L021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1823-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1823-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29

Product code OVE

K172424Class IIVelofix™ SA Cervical CageU&I Corporation / cleared 2017-11-22

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)