The Recall Desk

FDA (Devices) recall action 63618

Biomet 3i, LLC recalled 2 products on 2012-11-28

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2012-11-28
Critical
0
Units
267

Why these products were recalled

Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.

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

1–2 of 2

  • HighFDA (Devices)··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
    Distribution
    20 states
  • SevereFDA (Devices)··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
    Distribution
    20 states