FDA (Devices) recall action 79205
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.
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
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.
Allen Medical Systems is recalling 161 Radiolucent Surgery Spine Frames because the base may crack during patient transfer.
Allen Medical Systems is recalling 161 Bow Frame Model A-70800 surgical platforms because the base may crack when patients are transferred onto the device.