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.

151–175 of 222

  • ModerateFDA (Devices)·Z-2416-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

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

    Product
    Certain Pick-Up Coping 5mm(D) x 5mm(P) Item:IWIP55 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2406-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

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

    Product
    Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2420-2016·2016-08-24

    Biomet 3i Recalls Gold-Tite Hexed Retaining Screws Due to Sealing Defects

    Biomet 3i is recalling Gold-Tite Hexed Retaining Screws because pouches may not have been sealed during packing. The recall covers 1,648,273 units distributed worldwide.

    Product
    Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 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
  • ModerateFDA (Devices)·Z-2454-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

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

    Product
    Conical EP Pick-Up Coping (Non-Hexed) Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2461-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling DAL-RO Threaded Female Dental implants because pouches may not have been sealed during packing.

    Product
    DAL-RO Threaded Female Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2484-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 Implant EP Twist Lock Coping Dental Implants because pouches may not have been sealed during packing.

    Product
    Certain Implant EP Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2492-2016·2016-08-24

    Biomet 3i Recalls Preformance Post Dental Implants Due to Sealing Defects

    Biomet 3i is recalling Preformance Post Dental implants because pouches may not have been sealed during packing. The recall covers 1,648,273 devices distributed worldwide.

    Product
    Certain Preformance Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2482-2016·2016-08-24

    Biomet 3i Recalls Hex Try-in Screws Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Hex Try-in Screws because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Certain Hex Try-in Screw (5 pk) Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2429-2016·2016-08-24

    Biomet 3i Recalls Locator Extra Light Retention Dental Implant Pouches

    Biomet 3i is recalling Locator Extra Light Retention Males dental implant pouches because they may not have been sealed during packing.

    Product
    Locator Extra Light Retention Males 4pk 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-2514-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 Conical 25 degree Angled Abutment Dental Implants because pouches may not have been sealed during packing.

    Product
    Certain Conical 25 degree Angled Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2417-2016·2016-08-24

    Biomet 3i Recalls Straight Healing Abutments Due to Sealing Defects

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

    Product
    Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2413-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

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

    Product
    Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2418-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling specific dental implant copings because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2452-2016·2016-08-24

    Biomet 3i Recalls Conical EP Healing Caps Due to Sealing Defects

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

    Product
    Conical EP Healing Cap Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2409-2016·2016-08-24

    Biomet 3i Recalls Certain Gingihue Dental Implants Due to Sealing Defects

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

    Product
    Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2491-2016·2016-08-24

    Biomet 3i Recalls Preformance Dental Implants Due to Unsealed Pouches

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

    Product
    Certain Preformance 15 degrees Pre-Angled Post 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