Recall Z-2128-2016— Exactech, Inc.

Name: FDA recall Z-2128-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-26

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2016-05-26, terminated 2019-07-26. It names one FDA 510(k) clearance: K063279. 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 stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation.. Reason: Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-05-26
Terminated: 2019-07-26
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K063279 — NOVATION SPLINED RDD FEMORAL STEMSExactech, Inc.·cleared 2006-11-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.