FDA (Devices) recall action 98340
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Knee and Humeral socket implants contain incorrect labeling.
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.
Encore Medical, LP is recalling 14 EMPOWR 3D KNEE implants because they contain incorrect labeling. The recall affects US nationwide distribution.
Encore Medical, LP is recalling 20 Reverse Shoulder Prosthesis implants due to incorrect labeling. The recall affects nationwide distribution across multiple US states.
Encore Medical is recalling Reverse Shoulder Prosthesis humeral socket inserts, catalogue number 509-00-432, because knee and humeral socket implants contain incorrect labeling.