FDA (Devices) recall action 92520
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.
A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & 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.
AEQUALIS FLEX REVIVE assembly screws were mislabeled during manufacturing, with some units marked as 0mm Standard actually being 0mm Short and vice versa. Surgeons must verify model numbers before use.
Tornier recalled 55 AEQUALIS FLEX REVIVE Assembly Screws (Model ARS655101) due to a labeling swap where Standard-length units were marked Short, and vice versa. This could result in implantation of the wrong screw size during orthopedic surgery.