Exactech, Inc. recalls Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use

Recalled June 8, 2016 · FDA recall Z-1900-2016 · Exactech

Hazard

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

Units

3 devices

Sold at

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

Description

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

Product

Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.

Manufacturer(s)

Exactech, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →