FDA (Devices) recall action 84450
The FDA (Devices) publishes a recall like this one as 24 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 24 pages.
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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 7 units of Abutment Screw Retrieval Kits because a packaging sealing issue may compromise the sterility of the included medical devices.
Nobel Biocare is recalling Guided Start Drills because a packaging sealing issue may compromise the sterility of the devices during their shelf life.
Nobel Biocare is recalling specific dental drills because a packaging defect may compromise their sterility during shelf life.
Nobel Biocare is recalling Dense Bone Drills because a packaging sealing issue may compromise sterility during shelf life.
Nobel Biocare is recalling specific tapered dental drills because a packaging defect may compromise their sterility during shelf life.
Nobel Biocare is recalling 346 Guided Tapered Drills because a packaging sealing issue may compromise sterility during shelf life.
Nobel Biocare is recalling Screw Tap Tapered WP Single-Pat devices because a packaging sealing defect may compromise sterility during shelf life.
Nobel Biocare is recalling 260 units of tapered dental drills because a packaging sealing issue may compromise sterility during shelf life.
Nobel Biocare is recalling 11 units of Implant Retrieval Instrument Tri Channel 6.0 22 mm because a packaging sealing issue may compromise sterility.
Nobel Biocare is recalling 264 tapered dental drills because a packaging sealing defect may compromise sterility during shelf life.
Nobel Biocare is recalling 233 units of Abutment Screw Retrieval Instruments because a packaging defect may compromise sterility during shelf life.
Nobel Biocare is recalling 8 Dense Bone Drills because a packaging defect may compromise sterility during shelf life.
Nobel Biocare is recalling 8 units of tapered dental drills because a packaging sealing issue may compromise sterility during shelf life.
Nobel Biocare is recalling 423 implant retrieval instruments because a packaging defect may compromise sterility during shelf life.
Nobel Biocare is recalling 31 units of Implant Retrieval Instrument CC 3.0 31 mm because a packaging sealing defect may compromise sterility.
Nobel Biocare is recalling 2,470 implant retrieval instruments because a packaging defect may compromise sterility. The devices are distributed worldwide.
Nobel Biocare is recalling 87 units of Implant Retrieval Kits because a packaging sealing issue may compromise the sterility of the devices during their shelf-life.
Nobel Biocare is recalling 132 units of Abutment Screw Retrieval Instrument RP/WP/6.0 because a packaging sealing issue may compromise sterility during shelf life.
Nobel Biocare is recalling 473 tapered dental drills because a packaging defect may compromise sterility during shelf life.
Nobel Biocare is recalling Dense Bone Drills because a packaging defect may compromise sterility during shelf life.
Nobel Biocare is recalling 197 implant retrieval instruments because a packaging defect may compromise sterility during shelf life.
Nobel Biocare is recalling 59 dental drills because a packaging defect may compromise sterility. The devices are distributed worldwide.
Nobel Biocare is recalling 526 Implant Retrieval Instruments because a packaging sealing issue may compromise sterility during shelf life.
Nobel Biocare is recalling 154 units of Tapered RP 4.3x13 mm drills because a packaging defect may compromise sterility.