Device Recall ULTIMALX STM

  • Model / Serial
    Product code: 853157 and Lot numbers: 475235, 639640, 640919, 662465, XBK76, XCE42, XCU47, XEW27, XFE23, XFX43, XHL13, YAX30, YDW82, YEK32, YFE46, and YKK07.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

7 devices with a similar name

Learn more about the data here

  • Model / Serial
    Product code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Product Description
    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
  • Model / Serial
    Product code: 853153 and Lot numbers: 438750, 604146, 660441, 0858531531, XCU42, XFE20, YAX29, YCT82, and YEG20.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Product Description
    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
  • Model / Serial
    Product code: 853154 and Lot numbers: 438751, 438880, 633705, XCU43, and XFE21
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Product Description
    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
  • Model / Serial
    Product code: 853155 and Lot numbers: 438752, 475234, 633707, and XBK74.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Product Description
    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
  • Model / Serial
    Product code: 853156 and Lot numbers: 438753, 438882, 633709, 577070U, XBK75, XCE41, XCU45, XFE22, XHL11, and XHL12
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • Product Description
    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
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