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.

26–50 of 222

  • ModerateFDA (Devices)·Z-1371-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Misalignment

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

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1367-2020·2020-03-04

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

    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 3.8MM(P) X 4MM(H) Reference Number: IEHA344
    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-1388-2020·2020-03-04

    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 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574
    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
  • HighFDA (Devices)·Z-2142-2019·2019-08-14

    Biomet 3i Recalls Certain Bellatek Titanium Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 6 units of Certain Bellatek Titanium Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.

    Product
    CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2140-2019·2019-08-14

    Biomet 3i Recalls Certain Bellatek Tin Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 3 units of Bellatek Tin Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.

    Product
    CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2141-2019·2019-08-14

    Biomet 3i Recalls Titanium Dental Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 17 units of Certain Bellatek Titanium Abutments because a manufacturing defect prevents the screw from seating correctly.

    Product
    CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2144-2019·2019-08-14

    Biomet 3i Recalls Titanium Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 49 units of Certain Bellatek Titanium Abutments because a manufacturing defect prevents the screw from seating correctly.

    Product
    CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2143-2019·2019-08-14

    Biomet 3i Recalls Certain Bellatek Tin Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 2 units of Bellatek Tin Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.

    Product
    CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1701-2017·2017-04-05

    Biomet 3i Recalls Dental Implants Due to Potential Label Mismatch

    Biomet 3i is recalling five units of LTX dental implants because a single part in the lot may not match the label due to a supplier error.

    Product
    BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0833-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 150 dental implant abutments because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0836-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 101 units of a specific dental implant abutment because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0844-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling a limited number of dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0841-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 525 low-profile dental implant abutments because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0852-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 50 units of Low Profile Abutments because some pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0858-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Unsealed Packaging

    Biomet 3i is recalling 270 low-profile dental implant abutments because some pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0843-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 108 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0829-2017·2016-12-28

    Biomet 3i Low Profile Dental Implant Abutments Recalled for Packaging Defect

    Biomet 3i is recalling 53 units of Low Profile 17° Abutments because some pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0849-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i, LLC is recalling 160 units of Low Profile Abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0845-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling a limited number of Low Profile 30-degree abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0863-2017·2016-12-28

    Biomet 3i Low Profile Abutment Titanium Retaining Screw Recall

    Biomet 3i is recalling 1,633 Low Profile Abutment Titanium Retaining Screws because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0859-2017·2016-12-28

    Biomet 3i Low Profile Abutment Quickbridge Recall for Unsealed Pouches

    Biomet 3i is recalling 60 units of Low Profile Abutment Quickbridge because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0831-2017·2016-12-28

    Biomet 3i Low Profile Dental Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 735 low profile dental abutments because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0846-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 246 dental implant abutments because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states