The Recall Desk

FDA (Devices) recall action 66204

Biomet 3i, LLC recalled 2 products on 2013-09-25

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
2013-09-25
Critical
0
Units
393

Why these products were recalled

One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.

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

  • ModerateFDA (Devices)··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
    Distribution
    19 states
  • ModerateFDA (Devices)··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
    Distribution
    19 states