FDA (Devices) recall action 73200
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Exactech is recalling four Novation femoral stems because they were packaged before the required site-change approval was granted.
Exactech is recalling three Novation Ceramic AHS Cluster-Hole Shells because they were packaged before the required site-change approval was granted.
Exactech is recalling nine Novation femoral stems because they were packaged before receiving FDA approval for a site change.
Exactech is recalling two Novation Ceramic AHS Cluster-Hole Shell acetabular cups because they were packaged before regulatory approval.
Exactech is recalling one Novation femoral stem device because it was packaged before the required FDA site-change approval was granted.
Exactech is recalling one Novation femoral stem device because it was packaged before the required site-change approval was granted.