Exactech, Inc. recalls Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems are indic…

Recall date

May 26, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2128-2016

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.