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

Agency Publication Date: July 5, 2016

Affected Products

Product: 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 s

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: 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

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.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74317

Status: Resolved

Manufacturer: Exactech, Inc.

Manufactured In: United States

Units Affected: 2 products (8 units; 14)

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Sources: FDA iRES · Raw API Response

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Affected Products

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.