Devices

Device Recall Rotate, BulletTip, TPlus, Contact, Crossfuse, and CrossFuse II, Interbody Fusion/Vertebral Body Re

  • Modelo / Serial
    Part Number: 32-13-32 Lot: 200827 Expiration Date: 2019-12-18 Part Number: 30-T-13-6 Lot: 202726 Expiration Date: 2020-01-16  Part Number: 30-T-1036-13-6 Lot: 202582 Expiration Date: 2020-01-15
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to the states of : FL and NY
  • Descripción del producto
    Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-1036-13-6 UDI (01)00846468032760(17)200115(10)202582. These products are part of the lnterbody Fusion Vertebral || Body Replacement System to ensure stability of the spine and adequate compression of the implant.
  • Manufacturer
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
  • 1 Event

Fabricante

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
  • Dirección del fabricante
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), 375 River Park Cir, Marquette MI 49855-1781
  • Empresa matriz del fabricante (2017)
    RTI Surgical Inc
  • Source
    USFDA