FDA (Devices) recall action 70821
The FDA (Devices) publishes a recall like this one as 27 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 27 pages.
A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads..
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.
Nobel Biocare is recalling 106 units of NobelReplace CC RP 5.0x13mm dental implants because packaging material may leave a sticky substance on the implant surfaces.
Nobel Biocare is recalling 56 dental implants because packaging material may leave a sticky substance on the implant surfaces.