FDA (Devices) recall action 74850
The FDA (Devices) publishes a recall like this one as 8 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 8 pages.
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
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.
Medtronic is recalling two units of Alpha total knee replacement tibial trays that may not have been passivated according to job traveler requirements.
Medtronic is recalling three units of tibial tray components for total knee replacement because they may not have been passivated correctly.
Medtronic Sofamor Danek USA Inc is recalling four units of Alpha total knee replacement femoral components that may not have been passivated according to requirements.
Medtronic is recalling Alpha total knee replacement femoral components that may not have been passivated according to job traveler requirements.
Medtronic is recalling three units of tibial tray components for total knee replacement because they may not have been passivated according to requirements.
Medtronic is recalling specific Alpha total knee replacement tibial trays that may not have been passivated according to manufacturing requirements.
Medtronic Sofamor Danek is recalling specific total knee replacement femoral components that may not have been passivated correctly.
Medtronic is recalling three units of Alpha total knee replacement femoral components because they may not have been passivated according to job traveler requirements.