FDA recall Z-1823-2020

U&I CORP. · Class II · device

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.

Distribution

US Nationwide distribution in the state of CA.

Key facts

Status
Terminated
Initiation date
2019-01-30
Report date
2020-05-06
Termination date
2020-11-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Uijeongbu-Si Gyeonggi-Do, N/A, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1823-2020