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.

201–222 of 222

  • ModerateFDA (Devices)·Z-1410-2015·2015-04-22

    Biomet 3i Recalls Discolored OSSEOTITE Tapered Dental Implants

    Biomet 3i is recalling 620 OSSEOTITE Tapered dental implants because contact with residual machine fluid caused discoloration.

    Product
    OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1409-2015·2015-04-22

    Biomet 3i Recalls T3 Dental Implants Due to Machine Fluid Discoloration

    Biomet 3i, LLC is recalling 620 T3 Non-Platform Switched Tapered Dental Implants because contact with residual machine fluid caused discoloration.

    Product
    3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1411-2015·2015-04-22

    Biomet 3i Recalls Discolored OSSEOTITE Dental Implants

    Biomet 3i is recalling 620 OSSEOTITE dental implants that were discolored due to contact with residual machine fluid.

    Product
    OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2594-2014·2014-09-17

    Biomet 3i Healing Abutments Recalled for Incorrect Label Color Coding

    Biomet 3i is recalling 6 units of Bellatek Encode Healing Abutments because the labels have incorrect color coding, though the identifiers are correct.

    Product
    BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1215-2014·2014-03-26

    Biomet 3i Recalls BellaTek Zirconia Dental Abutments Due to Fracture Reports

    Biomet 3i is recalling BellaTek Zirconia Dental Abutments because of reports of fractures. The recall covers 10,454 units distributed worldwide.

    Product
    Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1233-2014·2014-03-26

    Biomet Recalls Endobon Xenograft Granules Due to Incorrect Batch Labels

    Biomet 3i, LLC is recalling 704 units of Endobon Xenograft Granules 0.5 ML because individual pieces may have incorrect labels with the wrong batch number.

    Product
    ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1171-2014·2014-03-19

    Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

    Biomet 3i is recalling 181 dental torque driver kits because they failed to meet required sterility assurance levels during validation testing.

    Product
    Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2014·2014-03-19

    Biomet 3i Recalls Navigator Surgical Kits Due to Sterility Assurance Failure

    Biomet 3i, LLC is recalling 21 units of the Navigator Surgical Kit because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2014·2014-03-19

    Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

    Biomet 3i is recalling 541 Contra-Angle Torque Driver Kits because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1170-2014·2014-03-19

    Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

    Biomet 3i is recalling 250 Contra-Angle Torque Driver Kits because the included surgical trays failed to meet required Sterility Assurance Levels during validation testing.

    Product
    Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1168-2014·2014-03-19

    Biomet 3i Recalls Tapered Navigator Surgical Kits Due to Sterility Failure

    Biomet 3i is recalling 170 Tapered Navigator Certain Surgical Kits because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2207-2013·2013-09-25

    Biomet 3i Recalls Dental Implants Lacking Internal Hex and Thread Features

    Biomet 3i is recalling 215 Osseotite 2 Certain Prevail dental implants because some units lack the internal hex and thread features required for proper prosthetic attachment.

    Product
    Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single te
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2208-2013·2013-09-25

    Biomet 3i Recalls Dental Implants Lacking Internal Hex and Thread Features

    Biomet 3i, LLC is recalling 178 Osseotite Parallel Walled dental implants because some units are missing the internal hex and internal thread features.

    Product
    Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utiliz
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1961-2013·2013-08-21

    Biomet 3i Dental Implant Recall for Potential Outer Box Mislabeling

    Biomet 3i is recalling 33 dental implants because outer boxes may be mislabeled. The inner trays are correctly labeled, but the error could prevent proper implant placement.

    Product
    Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1960-2013·2013-08-21

    Biomet 3i Dental Implant Recall Due to Outer Box Mislabeling

    Biomet 3i is recalling 51 dental implants because outer boxes may be mislabeled. The implants themselves are correctly labeled, but the error could prevent proper placement.

    Product
    Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0297-2013·2012-11-28

    Biomet 3i Recalls OSSEOTITE Dental Implants Due to Shallow Hex Depth

    Biomet 3i is recalling 191 OSSEOTITE dental implants because a manufacturing defect makes the internal hex too shallow, which may prevent the driver or abutment from fully engaging.

    Product
    Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utiliz
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0298-2013·2012-11-28

    Biomet 3i Recalls OSSEOTITE Dental Implants Due to Shallow Hex Depth

    Biomet 3i is recalling 76 OSSEOTITE dental implants because a manufacturing defect makes the internal hex too shallow, potentially preventing proper engagement of drivers or abutments.

    Product
    Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0119-2013·2012-10-31

    Biomet 3i Recalls Dental Implants Due to Missing Internal Threading

    Biomet 3i is recalling 227 Osseotite Tapered Certain Implants because a small percentage are missing internal threading. The devices were distributed worldwide.

    Product
    Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple si
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2271-2012·2012-09-05

    Biomet 3i Recalls Low Profile Abutments Due to Labeling Errors

    Biomet 3i is recalling Low Profile Abutments because some packages labeled as Hexed Castable Cylinders may contain Non-Hexed Castable Cylinders.

    Product
    Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing wit
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2158-2012·2012-08-15

    Biomet 3i Recalls Dental Implants Due to Shallow Internal Hex Depth

    Biomet 3i is recalling specific dental implants because the internal hex depth is too shallow, which may prevent components from fully engaging the implant.

    Product
    ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical placement
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1828-2012·2012-06-27

    Biomet 3i Recalls Dental Implants Due to Missing Internal Thread

    Biomet 3i is recalling specific Osseotite dental implants because they may lack an internal thread. The recall affects 219 units distributed in the US and internationally.

    Product
    Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide