FDA (Devices) recall action 73205
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.
Potential for abrasion of the sterile barrier pouches of the new packaging system.
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 USA Limited is recalling 629 Trinity Acetabular Shell devices used in total hip replacements due to a potential for abrasion of the sterile barrier pouches in the new packaging system.
Corin USA Limited is recalling 629 Trinity Acetabular System devices due to potential abrasion of sterile barrier pouches in the new packaging system.
Corin USA Limited is recalling 629 Trinity Acetabular Shells used in total hip replacements because the new packaging system may abrade the sterile barrier pouches.