The Recall Desk

Manufacturer

Biomet 3i, LLC

222 recalls in our database name Biomet 3i, LLC as the manufacturing or recalling firm.

What the numbers show

Total
222
Critical
0
Severe
1
Most recent
2020-10-14

Of the 222 recalls from Biomet 3i, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 222

  • HighFDA (Devices)·Z-0079-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Titanium Abutments

    Biomet 3i is recalling BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0073-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Encode Definitive Abutments

    Biomet 3i, LLC is recalling BellaTek Encode Definitive Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement in patients.

    Product
    BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0074-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Titanium Abutments

    Biomet 3i is recalling BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement in patients.

    Product
    BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0078-2021·2020-10-14

    Biomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment

    Biomet 3i is recalling 10 units of BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0077-2021·2020-10-14

    Biomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment

    Biomet 3i is recalling 35 units of BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0075-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Dental Abutments

    Biomet 3i is recalling 9 units of BellaTek Encode Definitive Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0076-2021·2020-10-14

    Biomet 3i Recalls BellaTek Abutments Due to Manufacturing Misalignment

    Biomet 3i is recalling 4 units of BellaTek abutments because the hex was misaligned by 30 degrees, preventing correct placement in patients.

    Product
    CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1372-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA354
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1369-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Misalignment

    Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation or margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1384-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in scanned data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1374-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Fit Issues

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1373-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1377-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1379-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because the resulting impression or scanned data may cause incorrect rotation and margin contour misalignment.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA464
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1386-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour misalignment in scanned data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1375-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1382-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1387-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1385-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in scanned data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1368-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number: IEHA346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1380-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466
    Category
    Medical Device
    Distribution
    Distributed nationwide