The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0266-2016·Announced 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.

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 source text describes a labeling error without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Biomet 3i, LLC is recalling 96 pieces of the Biomet 3i Narrow Right Angle Large Driver Tip (Hexed), Model # RASH3N, Lot # 1184555. These driver tips are attached to surgical drilling units to carry components such as implant mounts, healing abutments, and screws for placement and removal during dental and restorative procedures.

The recall was initiated because the RASH3N hexed driver tips were labeled and distributed as RASQ3N square driver tips. Additionally, the RASQ3N square driver tips received the RASH3N laser marking during manufacturing. This mislabeling could lead to the use of the wrong driver tip for specific dental components.

The affected products were distributed in the United States (including the District of Columbia) and in Argentina, Australia, Belgium, Canada, Colombia, Greece, Hong Kong, Ireland, Italy, South Korea, and Kuwait. Consumers and healthcare providers should stop using the affected driver tips and contact Biomet 3i, LLC for further instructions or a replacement.

The recalled product

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.
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Surgical Instrument
Hazard
Affected units
96

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 # RASH3N Lot # 1184555

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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