Exactech, Inc. recalls Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; F…

Recall date

April 12, 2016

Source

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

Recall number

Z-1905-2016

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.

Why it was recalled

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

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, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.