FDA (Devices) recall action 86402
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
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.
Biomet 3i is recalling 4 units of BellaTek abutments because the hex was misaligned by 30 degrees, preventing correct placement in patients.
Biomet 3i is recalling BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement in patients.
Biomet 3i is recalling 9 units of BellaTek Encode Definitive Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.
Biomet 3i is recalling 35 units of BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.
Biomet 3i is recalling 10 units of BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.
Biomet 3i, LLC is recalling BellaTek Encode Definitive Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement in patients.
Biomet 3i is recalling BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.