FDA (Devices) recall action 84593
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.
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.
Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the inner cap may open or the tube may remain in the outer cap, preventing screw removal.
Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the inner packaging cap may open or fail to separate, potentially delaying surgery.
Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the packaging may fail to keep the screw accessible, potentially delaying surgery.
Synthes is recalling 25 units of 2.4mm sterile locking screws because the inner packaging cap may open prematurely, potentially preventing the screw from being used during surgery.
Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the packaging may fail to keep the screw sealed, potentially causing surgical delays.