FDA (Devices) recall action 52634
The FDA (Devices) publishes a recall like this one as 31 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 31 pages.
The tulip portion of the screw assembly can disengage from the shank after implantation.
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.
NuVasive Inc is recalling 240 units of 5.5mm x 45mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
NuVasive Inc is recalling 240 units of Screw Tulip, 5.5mm Rod devices because the tulip portion can disengage from the shank after implantation.
NuVasive Inc is recalling 240 units of 7.5mm x 45mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
NuVasive Inc is recalling 240 units of 4.5mm x 35mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
NuVasive Inc is recalling 240 units of 5.5mm x 45mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
NuVasive Inc is recalling 240 units of 5.5mm x 50mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.