FDA (Devices) recall action 63665
The FDA (Devices) publishes a recall like this one as 9 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 9 pages.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
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.
DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.
DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.
DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.
DePuy Spine is recalling 36 units of VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.
DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.
DePuy Spine is recalling VIPER Polyaxial Screws 8x80mm and larger because the screw shank may separate from the head during high-torque insertion.
DePuy Spine is recalling VIPER polyaxial screws because the shank may separate from the head during high-torque insertion.
DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.
DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.