Biomet 3i Recalls
222 recalls on record · June 27, 2012 to October 14, 2020 · Medical Devices
Recalls by year
12
13
14
15
16
17
19
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 14, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
Hazard: 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
October 14, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
Hazard: 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
October 14, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
Hazard: 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
October 14, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
Hazard: 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
October 14, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
Hazard: 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
October 14, 2020Medical DevicesFDA
Biomet 3i, LLC recalls BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
Hazard: 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
October 14, 2020Medical DevicesFDA
Biomet 3i, LLC recalls BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA464
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA354
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number: IEHA346
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344
Hazard: 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
March 4, 2020Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343
Hazard: 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