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.

76–100 of 222

  • HighFDA (Devices)·Z-2503-2016·2016-08-24

    Biomet 3i Recalls Twist Lock Dental Implants Due to Unsealed Pouches

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

    Product
    Certain Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2410-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i is recalling specific Gingihue dental implants because their pouches may not have been sealed during packing.

    Product
    Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G. Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2478-2016·2016-08-24

    Biomet 3i Recalls IOL Titanium Temporary Cylinder Dental Implants

    Biomet 3i, LLC is recalling IOL Titanium Temporary Cylinder Dental implants because pouches may not have been sealed during packing.

    Product
    IOL Titanium Temporary Cylinder Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2455-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Conical EP Twist Lock TM Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Conical EP Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2509-2016·2016-08-24

    Biomet 3i Recalls EP Healing Abutments Due to Unsealed Pouches

    Biomet 3i is recalling specific EP Healing Abutments because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2501-2016·2016-08-24

    Biomet 3i Recalls Twist Lock Dental Implants Due to Unsealed Pouches

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

    Product
    Certain Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2483-2016·2016-08-24

    Biomet 3i Recalls Dental Implant Cover Screws Due to Sealing Defects

    Biomet 3i, LLC is recalling 1,648,273 dental implant cover screws because pouches may not have been sealed during packing.

    Product
    Certain Implant Cover Screw Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2437-2016·2016-08-24

    Biomet 3i Recalls Preformance Temporary Cylinder Dental Implants

    Biomet 3i is recalling Preformance Temporary Cylinder Dental implants because pouches may not have been sealed during packing.

    Product
    Preformance Temporary Cylinder Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2431-2016·2016-08-24

    Biomet 3i Recalls Locator Replacement Housing Dental Implants

    Biomet 3i, LLC is recalling Locator Replacement Housing dental implants because pouches may not have been sealed during packing.

    Product
    Locator Replacement Housing Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2426-2016·2016-08-24

    Biomet 3i Recalls Dental Implant O-Ring Abutments Due to Sealing Defect

    Biomet 3i is recalling specific lots of O-Ring Abutments for dental implants because pouches may not have been sealed during packing.

    Product
    O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2441-2016·2016-08-24

    Biomet 3i Dental Implants Recalled for Unsealed Pouches

    Biomet 3i is recalling 1.6 million dental implant protection caps because pouches may not have been sealed during packing.

    Product
    Provide Protection Cap Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2489-2016·2016-08-24

    Biomet 3i Recalls Non-Hexed Dental Implants Due to Sealing Defects

    Biomet 3i is recalling approximately 1.6 million non-hexed dental implants because pouches may not have been sealed during packing.

    Product
    Certain Non-Hexed Implant Pick-up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2495-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Standard Abutment Dental implants because pouches may not have been sealed during packing.

    Product
    Certain Standard Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2472-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Implant Twist Lock TM Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Implant Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2435-2016·2016-08-24

    Biomet 3i Recalls Preformance Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Preformance 15 degrees pre-angled post dental implants because pouches may not have been sealed during packing.

    Product
    Preformance 15 degrees pre-angled post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2444-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Standard Abutment Pick-Up Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Standard Abutment Pick -Up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2464-2016·2016-08-24

    Biomet 3i Recalls Gingihue Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Gingihue 15 Degree Pre-Angled Post Dental implants because pouches may not have been sealed during packing.

    Product
    Gingihue 15 Degree Pre-Angled Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2407-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i, LLC is recalling specific dental implant abutments because the packaging pouches may not have been sealed during packing.

    Product
    Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2516-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 dental implant cover screws because pouches may not have been sealed during packing.

    Product
    Certain Cover Screw Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide