FDA (Devices) recall action 87959
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.
Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
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.
Corin Ltd is recalling TriIFit TS size 2 hip prosthesis stems that were labeled incorrectly as TriFit CF size 7 stems, and vice versa. Patients receiving mismatched implants face risk of poor fit and potential complications.
Corin TriFit hip prosthesis components from lot 467881 were mislabeled, with size 2 stems labeled as size 7 and vice versa. Surgeons could implant incorrect components during hip replacement surgery.