Device Recall Apex ARC Hip Stem

  • Model / Serial
    Lot Numbers: 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688, 18070
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.
  • Product Description
    Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA || Product Usage: || The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Omnilife Science Inc., 50 Oconnell Way Ste 10, East Taunton MA 02718-1394
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot: 17284
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US: CA, OK, VA, FL, MA, NY, TX
  • Product Description
    Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
  • Manufacturer