FDA (Devices) recall action 92479
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.
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
The agency’s own wording, quoted from the enforcement report.
Osteomed is recalling orthopedic screws with undersized heads that may pass through bone plates. Affected lot numbers were distributed nationwide in the US and Singapore.
Osteomed recalls orthopedic AutoDrive screws used in osteotomy procedures due to undersized screw heads that could pass through the mounting plate hole, potentially affecting surgical fixation.