July 29, 2020Medical DevicesFDA
U&I CORP. recalls ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
Hazard: 6.0x50mm poly-reduction screws were laser etched 6.0x45
May 6, 2020Medical DevicesFDA
U&I CORP. recalls Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 -
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.