FDA (Devices) recall action 84771
The FDA (Devices) publishes a recall like this one as 23 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 23 pages.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
The agency’s own wording, quoted from the enforcement report.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment in dental impressions.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin contour misalignment in dental impressions.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour misalignment in dental impressions.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in scanned data.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment in dental impressions.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.
Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in scanned data.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because the resulting impression or scanned data may cause incorrect rotation and margin contour misalignment.
Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour misalignment in scanned data.
Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation or margin contour misalignment in dental impressions.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour misalignment in dental impressions.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment in dental impressions.
Biomet 3i, LLC is recalling specific lots of Bellatek Encode Healing Abutments because they may produce incorrect rotation or margin contour misalignment in scanned data.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment.
Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in dental impressions.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in dental impressions.
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.