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.

176–200 of 222

  • ModerateFDA (Devices)·Z-2419-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i, LLC is recalling Gingihue 15 degrees Pre-Angled Post dental implants because pouches may not have been sealed during packing.

    Product
    Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2459-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling DAL-RO Housing, Female Assembly dental implants because pouches may not have been sealed during packing.

    Product
    DAL-RO Housing, Female Assembly Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2518-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 EP Pick-Up Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Certain EP Pick-Up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2490-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

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

    Product
    Certain Pick-up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2493-2016·2016-08-24

    Biomet 3i Recalls Preformance Temporary Cylinder Dental Implants

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

    Product
    Certain Preformance Temporary Cylinder Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2512-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutment dental implants because pouches may not have been sealed during packing.

    Product
    Certain Bellatek Encode Healing Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2434-2016·2016-08-24

    Biomet 3i Recalls Pick-Up Impression Coping Dental Implants

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

    Product
    Pick-Up Impression Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2471-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

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

    Product
    Implant EP Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2430-2016·2016-08-24

    Biomet 3i Recalls Locator Light Retention Dental Implant Components

    Biomet 3i is recalling Locator Light Retention Replacement Males because pouches may not have been sealed during packing.

    Product
    Locator Light Retention Replacement Males 4pk Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2453-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Conical EP Pick-Up Coping dental implants because pouches may not have been sealed during packing.

    Product
    Conical EP Pick-Up Coping (Hexed) Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2446-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

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

    Product
    Standard Abutment Transfer Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2414-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

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

    Product
    Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P) Item: IIIC41 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2438-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Prep-tite Cap Dental implants because pouches may not have been sealed during packing.

    Product
    Prep-tite Cap Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2523-2016·2016-08-24

    Biomet 3i Recalls Certain Gingihue Post Dental Implants

    Biomet 3i is recalling certain Gingihue Post Dental implants because pouches may not have been sealed during packing.

    Product
    Certain Gingihue Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2511-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

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

    Product
    Certain EP Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0594-2016·2016-01-13

    Biomet 3i Recall Dental Impression Coping Kits for Biocompatibility Testing

    Biomet 3i is recalling 30,111 Provide Impression Coping Kits worldwide due to inadequate biocompatibility testing.

    Product
    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0592-2016·2016-01-13

    Biomet 3i Protection Cap Kits Recalled for Inadequate Biocompatibility Testing

    Biomet 3i is recalling 30,111 Protection Cap Kits worldwide due to inadequate biocompatibility testing. The devices are used as accessories for dental implants.

    Product
    BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0593-2016·2016-01-13

    Biomet 3i Dental Impression Copings Recalled for Inadequate Biocompatibility Testing

    Biomet 3i is recalling specific dental impression copings due to inadequate biocompatibility testing. The devices are distributed worldwide, including in the US.

    Product
    BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abut
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0591-2016·2016-01-13

    Biomet 3i Protection Caps Recalled for Inadequate Biocompatibility Testing

    Biomet 3i is recalling specific Protection Caps due to inadequate biocompatibility testing. The devices are distributed worldwide, including the US.

    Product
    BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accesso
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0564-2016·2016-01-06

    Biomet 3i Recalls Radiographic Transparencies Due to Undersized Images

    Biomet 3i is recalling 686 radiographic transparencies because the images are undersized, which may affect dental implant measurements.

    Product
    Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0267-2016·2015-11-18

    Biomet 3i Dental Driver Tip Recalled for Mislabeling

    Biomet 3i is recalling 103 Narrow Right Angle Square Driver Tips that were mislabeled as hexed tips, creating a risk of improper use during dental procedures.

    Product
    Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental and restorative procedures.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0266-2016·2015-11-18

    Biomet 3i Dental Driver Tips Recalled for Mislabeling

    Biomet 3i is recalling 96 dental driver tips because hexed tips were labeled as square tips, and square tips were marked with hexed identifiers.

    Product
    Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental and restorative procedures.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2760-2015·2015-09-23

    Biomet 3i Recalls Mislabelled UCLA Dental Abutment Cylinders

    Biomet 3i is recalling 61 UCLA Abutment Hexed Castable Cylinders because they were mislabeled as a different model. The error affects one specific lot distributed worldwide.

    Product
    UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.
    Category
    Medical Device
    Distribution
    0 states