The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0267-2016·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a labeling error that could lead to improper use of a medical device, fitting the criteria for a moderate severity recall.

Plain-English summary

Biomet 3i, LLC is recalling 103 pieces of the Biomet 3i Narrow Right Angle Square Driver Tip (Model # RASQ3N, Lot # 1184554). These driver tips are used in dental and restorative procedures to attach to a surgical drilling unit for placing and removing implant components.

The recall is due to a labeling and manufacturing error. The recalled square driver tips were labeled and distributed as RASH3N, which is a hexed abutment screw driver tip. Additionally, the recalled items received the laser marking "RASH3N" during the manufacturing process. This misidentification could lead to the use of the wrong driver tip during surgical procedures.

The affected products were distributed in the United States (including the District of Columbia) and in several international locations, including Argentina, Australia, Belgium, Canada, Colombia, Greece, Hong Kong, Ireland, Italy, South Korea, and Kuwait. Healthcare professionals and consumers should stop using these specific driver tips and contact Biomet 3i for instructions on how to return the product.

The recalled product

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.
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Surgical Instrument
Hazard
Affected units
103

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model # RASQ3N Lot # 1184554

Distribution

Distributed in 30 states:

Part of a larger recall action

This product is one of 2 recalled by Biomet 3i, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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