Recall Z-1900-2016— Exactech, Inc.

Name: FDA recall Z-1900-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-12

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2016-04-12, terminated 2019-07-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-12
Terminated: 2019-07-24
Firm location: Gainesville, FL, United States

Product description

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.

Reason for recall

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

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