The Recall Desk
ModerateFDA (Devices)·Z-2489-2016·Announced 2016-08-24

Biomet 3i Recalls Non-Hexed Dental Implants Due to Sealing Defects

Biomet 3i is recalling approximately 1.6 million non-hexed dental implants because pouches may not have been sealed during packing.

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. The hazard is a packaging defect (unsealed pouches) which is a low-risk contamination or labeling/packaging issue without reported injuries, fitting the Moderate criteria for minor defects or voluntary precautionary recalls.

Plain-English summary

Biomet 3i, LLC is recalling approximately 1,648,273 units of Non-Hexed Implant Pick-up Coping Dental implants (Item: IMCSF34). The recall was initiated because the product pouches may not have been sealed during the packing process.

The affected devices were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries. The source text does not specify the exact dates of distribution or the specific medical facilities where the devices were used.

Consumers and healthcare providers should stop using these specific dental implants and contact Biomet 3i, LLC for instructions on how to return the devices. The recall is classified as Class II by the FDA, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Certain Non-Hexed Implant 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)

  • Item: IMCSF34

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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