Devices

Device Recall Femoral Stems

  • Model / Serial
    Catalog #: 160-33-18; Serial#: 4300062, 4300063; Exp Date: 02/27/2021. Catalog #: 160-33-18; Serial#:4325742, 4325743, 4325744, 4325745, 4325746, 4325747, 4325748, 4325749, 4325750, 4325751, 4325752, 4325753; Exp Date: 03/17/2021.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribuiton to OK, ME, NY, & Hawaii.
  • Product Description
    Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. || Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation.
  • Manufacturer
    Exactech, Inc.
  • 1 Event

Manufacturer

Exactech, Inc.
  • Manufacturer Address
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Manufacturer Parent Company (2017)
    Exactech Inc
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Femoral Stems
  • Model / Serial
    Catalog #: 160-33-17; Serial#: 4192419, 4192420; Exp Date: 11/28/2020. Catalog #: 160-33-17; Serial#: 4223628, 4223629, 4223630, 4223631, 4223632, 4223633; Exp Date: 01/02/2021.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribuiton to OK, ME, NY, & Hawaii.
  • Product Description
    Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. || Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation.
  • Manufacturer
    Exactech, Inc.