Devices

Device Recall Encompass Hip Stem, Plasma Spray

  • Modèle / numéro de série
    REF Number 109-1019, 1217, 1219, 1223, 1419, 1421, 1423, 1425, 1623, 1625, 1627, 1825, 1827.All Lot numbers.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution - USA including CA, FL, and TX.
  • Description du dispositif
    Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho Development, Draper, Utah 84020. || Intended for use in total hip arthroscopy. Device fixation is achieved by an optimal, press-fit in the medullary canal, which maximizes contact between the stem and the bone.
  • Manufacturer
    Ortho Development Corporation
  • 1 Event

Fabricant

Ortho Development Corporation
  • Adresse du fabricant
    Ortho Development Corporation, 12187 South Business Park Dr, Draper UT 84020
  • Société-mère du fabricant (2017)
    Ortho Development Corporation
  • Source
    USFDA

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Device Recall Encompass Hip Stem, Plasma Spray
  • Modèle / numéro de série
    REF Number 108- 1017, 1019, 1217, 1219, 1221, 1223, 1419, 1421, 1423, 1425, 1623, 1625, 1627, 1825, 1827. All Lot numbers.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution - USA including CA, FL, and TX.
  • Description du dispositif
    Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-XXXX, Sterile R, Ortho Development, Draper, Utah 84020. || Intended for use in total hip arthroscopy. Device fixation is achieved by an optimal, press-fit in the medullary canal, which maximizes contact between the stem and the bone.
  • Manufacturer
    Ortho Development Corporation