FDA (Devices) recall action 85218
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Reports received of the device fracturing during insertion.
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.
CTL Medical Corporation is recalling 39 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.
CTL Medical Corporation is recalling 46 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.
CTL Medical Corporation is recalling 39 units of CEZANNE II TLIF Bullet-Tip Cage because reports indicate the device fractured during insertion.
CTL Medical Corporation is recalling 45 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.