Recall Z-1823-2020— U&I CORP.

Name: FDA recall Z-1823-2020
Creator: U.S. Food and Drug Administration
Published: 2019-01-30

Class II · Terminated

Class II FDA medical device recall by U&I CORP., initiated 2019-01-30, terminated 2020-11-20. It names one FDA 510(k) clearance: K172424. 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: 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..

Recalling firm: U&I CORP.
Classification: Class II
Status: Terminated
Initiated: 2019-01-30
Terminated: 2020-11-20
Firm location: Uijeongbu-Si Gyeonggi-Do, N/A, Korea (the Republic of)

510(k) clearances named in this recall

1 on FDA's record

K172424 — Velofix SA Cervical CageU&I Corporation·cleared 2017-11-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.