Device Recall Encompass Hip Stem, Plasma Spray

  • Model / Serial
    REF Number 109-1019, 1217, 1219, 1223, 1419, 1421, 1423, 1425, 1623, 1625, 1627, 1825, 1827.All Lot numbers.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - USA including CA, FL, and TX.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ortho Development Corporation, 12187 South Business Park Dr, Draper UT 84020
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    REF Number 108- 1017, 1019, 1217, 1219, 1221, 1223, 1419, 1421, 1423, 1425, 1623, 1625, 1627, 1825, 1827. All Lot numbers.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - USA including CA, FL, and TX.
  • Product Description
    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