The Recall Desk
ModerateFDA (Devices)·Z-2497-2016·Announced 2016-08-24

Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

Biomet 3i is recalling specific dental implants because their pouches may not have been sealed during packing, potentially compromising sterility.

What this means for you

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, but the specific defect (unsealed pouches) is a packaging issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Biomet 3i, LLC is recalling certain Straight Pick Up Coping Dental implants (items IMIC30 and IWIP60) because the pouches containing the devices may not have been sealed during the packing process. This defect could compromise the sterile barrier of the packaging.

The recall involves 1,648,273 devices. These products were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries. The agency has classified this as a Class II recall.

Consumers and healthcare providers should stop using these specific dental implants and contact Biomet 3i, LLC for further instructions on how to return or replace the affected devices.

The recalled product

Product
Certain Straight Pick Up Coping Dental implants
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Implants
Hazard
Affected units
1,648,273

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)

  • Items: IMIC30 and IWIP60

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 119 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 119 products in this recall →

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