U&I CORP.: Medical Device Recall in 2020 - (Recall #: Z-1823-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: January 30, 2019

Date Posted: May 6, 2020

Recall Number: Z-1823-2020

Event ID: 84989

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.

Status: Terminated

Product Quantity: 42

Code Information:

Lots: A18K220, A18L065, A18L013, A18L014, A18L015, A18L018, A18L019, A18L020, A18L021

Distribution Pattern:

US Nationwide distribution in the state of CA.

Voluntary or Mandated:

Voluntary: Firm initiated