Device Recall ULTIMALX STM

  • Modelo / Serial
    Product code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Descripción del producto
    ULTIMA*LX STM,POL 10/12TAP/SZ2 || Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. || Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
  • Manufacturer
  • 2 Event

Fabricante

  • Dirección del fabricante
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

7 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Product code: 853153 and Lot numbers: 438750, 604146, 660441, 0858531531, XCU42, XFE20, YAX29, YCT82, and YEG20.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Descripción del producto
    ULTIMA*LX STM,POL 10/12TAP/SZ3 || Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. || Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
  • Manufacturer
  • Modelo / Serial
    Product code: 853154 and Lot numbers: 438751, 438880, 633705, XCU43, and XFE21
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Descripción del producto
    ULTIMA*LX STM,POL 10/12TAP/SZ4 || Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. || Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
  • Manufacturer
  • Modelo / Serial
    Product code: 853155 and Lot numbers: 438752, 475234, 633707, and XBK74.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Descripción del producto
    ULTIMA*LX STM,POL 10/12TAP/SZ5 || Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. || Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
  • Manufacturer
  • Modelo / Serial
    Product code: 853156 and Lot numbers: 438753, 438882, 633709, 577070U, XBK75, XCE41, XCU45, XFE22, XHL11, and XHL12
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Descripción del producto
    ULTIMA*LX STM,POL 10/12TAP/1M || Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. || Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
  • Manufacturer
  • Modelo / Serial
    Product code: 853157 and Lot numbers: 475235, 639640, 640919, 662465, XBK76, XCE42, XCU47, XEW27, XFE23, XFX43, XHL13, YAX30, YDW82, YEK32, YFE46, and YKK07.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Descripción del producto
    ULTIMA*LX STM,POL 10/12TAP/2M || Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. || Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
  • Manufacturer
2 más