Velofix SA cervical cage — Class II medical device recall Z-1823-2020

Terminated recall by U&I CORP., reported 2020-05-06, distributed nationwide. The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering d

Recall number	`Z-1823-2020`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	U&I CORP., Uijeongbu-Si Gyeonggi-Do, N/A, Korea (the Republic of)
Recall initiated	2019-01-30
Classified	2020-04-29
Reported by FDA	2020-05-06
Terminated	2020-11-20
Distributed	Nationwide (US)
Quantity	42
Lot numbers	`A18K220`, `A18L013`, `A18L014`, `A18L015`, `A18L018`, `A18L019`, `A18L020`, `A18L021`, `A18L065`
Model numbers	`TSA161207`, `TSA161208`, `TSA161209`, `TSA161210`, `TSA161407`, `TSA161408`, `TSA161409`, `TSA161410`

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1823-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.