Device Recall ULTIMALX STM

  • Modèle / numéro de série
    Product code: 853153 and Lot numbers: 438750, 604146, 660441, 0858531531, XCU42, XFE20, YAX29, YCT82, and YEG20.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Société-mère du fabricant (2017)
  • Source
    USFDA

7 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Product code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Product code: 853154 and Lot numbers: 438751, 438880, 633705, XCU43, and XFE21
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Product code: 853155 and Lot numbers: 438752, 475234, 633707, and XBK74.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Product code: 853156 and Lot numbers: 438753, 438882, 633709, 577070U, XBK75, XCE41, XCU45, XFE22, XHL11, and XHL12
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Product code: 853157 and Lot numbers: 475235, 639640, 640919, 662465, XBK76, XCE42, XCU47, XEW27, XFE23, XFX43, XHL13, YAX30, YDW82, YEK32, YFE46, and YKK07.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Description du dispositif
    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 en plus