Biomet 3i Recalls
222 recalls on record · June 27, 2012 to October 14, 2020 · Medical Devices
Recalls by year
12
13
14
15
16
17
19
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 14, 2019Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are int
Hazard: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
August 14, 2019Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intende
Hazard: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
August 14, 2019Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are in
Hazard: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
August 14, 2019Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are in
Hazard: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
August 14, 2019Medical DevicesFDA
Biomet 3i, LLC recalls CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intende
Hazard: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
April 5, 2017Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) un
Hazard: A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental implant abutment is a premanufactured pros
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING An endosseous dental implant abutment is a prem
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufacture
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured pr
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abutment is a premanufactured prosthetic compon
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous dental implant abutment is a pr
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a prema
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufact
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP An endosseous dental implant abutment is a premanufactured prosthetic compon
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured p
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured p
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured p
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured p
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthe
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosth
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthe
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthe
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthe
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufa
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufa
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufa
Hazard: A limited number of product pouches may not have been sealed during packaging.
December 28, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured pro
Hazard: A limited number of product pouches may not have been sealed during packaging.