The Recall Desk

FDA (Devices) recall action 72368

Biomet 3i, LLC recalled 2 products on 2015-11-18

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
2015-11-18
Critical
0
Units
199

Why these products were recalled

The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a square, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking "RASH3N" during manufacturing.

RASQ3N, a square, abutment screw driver tip has been labeled and distributed as RASH3N, a hexed, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking "RASH3N" during manufacturing.

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)··2015-11-18

    Biomet 3i Dental Driver Tips Recalled for Mislabeling

    Biomet 3i is recalling 96 dental driver tips because hexed tips were labeled as square tips, and square tips were marked with hexed identifiers.

    Product
    Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental and restorative procedures.
    Category
    Distribution
    30 states
  • ModerateFDA (Devices)··2015-11-18

    Biomet 3i Dental Driver Tip Recalled for Mislabeling

    Biomet 3i is recalling 103 Narrow Right Angle Square Driver Tips that were mislabeled as hexed tips, creating a risk of improper use during dental procedures.

    Product
    Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental and restorative procedures.
    Category
    Distribution
    30 states