Exactech, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2128-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 26, 2016

Date Posted: July 13, 2016

Recall Number: Z-2128-2016

Event ID: 74317

Reason for Recall:

Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.

Status: Terminated

Product Quantity: 14

Code Information:

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.

Distribution Pattern:

Nationwide Distribuiton to OK, ME, NY, & Hawaii.

Voluntary or Mandated:

Voluntary: Firm initiated