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.

101–125 of 222

  • 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-2424-2016·2016-08-24

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

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

    Product
    O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2456-2016·2016-08-24

    Biomet 3i Recalls Conical Healing Caps Due to Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 Conical Healing Caps for dental implants because pouches may not have been sealed during packing.

    Product
    Conical Healing Cap Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2477-2016·2016-08-24

    Biomet 3i Recalls IOL Pick-Up Impression Coping Due to Sealing Issues

    Biomet 3i is recalling IOL Pick-Up Impression Coping dental implant devices because pouches may not have been sealed during packing.

    Product
    IOL Pick-Up Impression Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2474-2016·2016-08-24

    Biomet 3i Recalls Dental Implant Abutments Due to Sealing Defects

    Biomet 3i is recalling IOL Abutment and Screw dental implants because pouches may not have been sealed during packing.

    Product
    IOL Abutment and Screw Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2504-2016·2016-08-24

    Biomet 3i Recalls Conical 17 Degree Angled Abutment Dental Implants

    Biomet 3i, LLC is recalling Conical 17 degree Angled Abutment dental implants because pouches may not have been sealed during packing.

    Product
    Conical 17 degree Angled Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2422-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 LDA Screw SBL 3mm(D) dental implants because pouches may not have been sealed during packing.

    Product
    LDA Screw SBL 3mm(D) Item: SCRSBL1 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-2408-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

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

    Product
    Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H) Item: IWTH564 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2500-2016·2016-08-24

    Biomet 3i Recalls Titanium Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling 1,648,273 titanium dental implants because pouches may not have been sealed during packing.

    Product
    Certain Titanium Large Hexed Screw 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-2485-2016·2016-08-24

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

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

    Product
    Certain Implant Straight Cover Screw 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-2513-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

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

    Product
    Certain Conical 17 degree Angled Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2520-2016·2016-08-24

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

    Biomet 3i is recalling 1,648,273 Flat Implant Cover Screws because pouches may not have been sealed during packing.

    Product
    Certain Flat Implant Cover Screw Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2421-2016·2016-08-24

    Biomet 3i Recalls Gold-Tite Square Uniscrew Dental Implants Due to Sealing Issues

    Biomet 3i is recalling Gold-Tite Square Uniscrew dental implants because pouches may not have been sealed during packing. The recall affects 1,648,273 units distributed worldwide.

    Product
    Gold-Tite Square Uniscrew Item: UNISG Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2433-2016·2016-08-24

    Biomet 3i Recalls Locator Replacement Males Due to Unsealed Pouches

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

    Product
    Locator Replacement Males 4pk 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-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