FDA (Devices) recall action 90493
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.
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
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.
The FDA is recalling 399 units of the PRESTIGE RETRACTION GRASPER surgical instrument due to risk of weld separation between the handle and shaft. This defect could cause device malfunction during surgical procedures.
Aesculap Implant Systems is recalling PRESTIGE ATRAUMATIC GRASPER surgical instruments because the weld connecting the handle to the shaft may separate during use.