Devices

Device Recall SOL SYS F 9 CALC L 13.5MM LG

  • Modelo / Serial
    Product Code: 157225136 and Lot codes: AB8GM1000, AF7KD1000, AF7KE1000, AF7KEC, AF7KG1000, AV7JY1000, AV7JYA000, AW8FY1000, AW8FYA000, AW8FYD, BR4KA1000, C77A51000, C77A5A000, CK6BR1000, DW2A31000, DW2A3A000, E1KKB1000, E3RLJ1000, EE5M81000, EP3BH1000, and FJ2L81.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR
  • Descripción del producto
    SOL SYS F 9 CALC L 13.5MM LG || Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. || Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
  • Manufacturer
    DePuy Orthopaedics, Inc.
  • 1 Event

Fabricante

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

Dispositivo con un nombre similar

Más información acerca de la data acá

Device Recall SOL SYS F 9 CALC L 13.5MM LG
  • Modelo / Serial
    Product Code: 157226136 and Lot codes: 126676, AB8GD1000, AB8GDA000, AF1EJ1000, AF1EK1000, AF1EKA000, AF1EKB000, AF7KF1000, AT4GJ1000, AT4GJA000, AW8FX1000, BR4KB1000, C4VCSA, C76FC1000, C82MV1000, D5LLL1000, D6DE51A, DG4FW1000, E5RKD1, E5RKDA, E79KF1, EJ4EJ1000, and FH8H6A.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR
  • Descripción del producto
    SOL SYS F 9 CALC L 13.5MM LG || Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. || Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
  • Manufacturer
    DePuy Orthopaedics, Inc.