Devices

Device Recall SOL SYS F 9 CALC L 13.5MM LG

  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    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
  • Description du dispositif
    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

Fabricant

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

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

Device Recall SOL SYS F 9 CALC L 13.5MM LG
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    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
  • Description du dispositif
    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.