The Recall Desk

FDA (Devices) recall action 82263

Biomet 3i, LLC recalled 5 products on 2019-08-14

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2019-08-14
Critical
0
Units
77

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • ModerateFDA (Devices)··2019-08-14

    Biomet 3i Recalls Certain Bellatek Tin Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 2 units of Bellatek Tin Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.

    Product
    CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-08-14

    Biomet 3i Recalls Certain Bellatek Titanium Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 6 units of Certain Bellatek Titanium Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.

    Product
    CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2019-08-14

    Biomet 3i Recalls Titanium Dental Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 17 units of Certain Bellatek Titanium Abutments because a manufacturing defect prevents the screw from seating correctly.

    Product
    CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2019-08-14

    Biomet 3i Recalls Titanium Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 49 units of Certain Bellatek Titanium Abutments because a manufacturing defect prevents the screw from seating correctly.

    Product
    CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-08-14

    Biomet 3i Recalls Certain Bellatek Tin Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 3 units of Bellatek Tin Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.

    Product
    CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Distribution
    1 state