Exactech, Inc. recalls Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use…

Recall date

April 12, 2016

Source

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

Recall number

Z-1901-2016

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 Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.