FDA (Devices) recall action 90882
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
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 is recalling EMPOWR hip liner implants because boxes may contain knee inserts instead. This packaging error could delay surgeries. Four units affected in six US states.
Hip and knee implant boxes from Encore Medical may contain the wrong product, potentially causing surgery delays. The FDA is recalling affected units to prevent unavailability of correct implants.