FDA-Device2020-05-06Class II
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.
U&I CORP.
Hazard
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.
Sold states
US Nationwide distribution in the state of CA.
Affected count
42
Manufactured in
20 Sandan-Ro 76 Beon-Gil, N/A, Uijeongbu-Si Gyeonggi-Do, N/A, Korea (the Republic of)
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1823-2020Don't want to check this manually?
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