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.

51–75 of 222

  • LowFDA (Devices)·Z-0855-2017·2016-12-28

    Biomet 3i Low Profile Abutment Healing Caps Recalled for Packaging Defects

    Biomet 3i is recalling 391 Low Profile Abutment Healing Caps because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP 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-0856-2017·2016-12-28

    Biomet 3i Dental Implant Abutment Recall for Packaging Seal Defects

    Biomet 3i is recalling 28 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING 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-0834-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 228 dental implant abutments because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(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
  • LowFDA (Devices)·Z-0847-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 175 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE 30¿ 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
  • LowFDA (Devices)·Z-0839-2017·2016-12-28

    Biomet 3i Low Profile One-Piece Abutment Recall for Packaging Seal Defects

    Biomet 3i is recalling 450 units of Low Profile One-Piece 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 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
  • LowFDA (Devices)·Z-0851-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 137 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i 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
  • LowFDA (Devices)·Z-0854-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 124 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i 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
  • LowFDA (Devices)·Z-0853-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 191 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ONE-PIECE 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
  • LowFDA (Devices)·Z-0830-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 27 specific dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN 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
  • LowFDA (Devices)·Z-0848-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 216 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i 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
  • LowFDA (Devices)·Z-0857-2017·2016-12-28

    Biomet 3i Low Profile Abutment Recall for Unsealed Packaging

    Biomet 3i is recalling 458 low profile abutment impression copings because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING 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-0861-2017·2016-12-28

    Biomet 3i Low Profile Abutment Recall for Unsealed Packaging

    Biomet 3i is recalling 1,371 low profile abutments because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED 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
  • LowFDA (Devices)·Z-0862-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 191 Low Profile Abutment units because some pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING 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-0828-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 127 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE 17¿ 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
  • LowFDA (Devices)·Z-0832-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling specific 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 30¿ 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
  • LowFDA (Devices)·Z-0838-2017·2016-12-28

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

    Biomet 3i is recalling 123 units of Low Profile Dental Abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN 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
  • LowFDA (Devices)·Z-0842-2017·2016-12-28

    Biomet 3i Dental Abutments Recalled for Potential Packaging Seal Defects

    Biomet 3i is recalling 46 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 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
  • LowFDA (Devices)·Z-0837-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 64 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE 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
  • LowFDA (Devices)·Z-0835-2017·2016-12-28

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

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

    Product
    BIOMET 3i CERTAIN LOW PROFILE 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
  • LowFDA (Devices)·Z-0850-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 204 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ONE-PIECE 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
  • LowFDA (Devices)·Z-0860-2017·2016-12-28

    Biomet 3i Low Profile Abutment Recall for Packaging Seal Defects

    Biomet 3i is recalling 108 low profile abutments because some pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT HEXED 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
  • LowFDA (Devices)·Z-0840-2017·2016-12-28

    Biomet 3i Low Profile Dental Abutment Recall 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 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-2845-2016·2016-09-28

    Biomet 3i Recalls 92 Dental Implants Due to Packaging Error

    Biomet 3i is recalling 92 units of 3I Osseotite dental implants because they were incorrectly packaged. The affected units were distributed in the US and several international countries.

    Product
    3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2462-2016·2016-08-24

    Biomet 3i Recalls Drill Stop Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Drill Stop Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Drill Stop Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide