The Recall Desk
ModerateFDA (Devices)·Z-2522-2016·Announced 2016-08-24

Biomet 3i Recalls Certain Gingihue Dental Implants Due to Sealing Issues

Biomet 3i, LLC is recalling certain Gingihue 15 degree Pre-Angled Post 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, and the hazard involves a packaging defect (unsealed pouches) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Biomet 3i, LLC is recalling certain Gingihue 15 degree Pre-Angled Post Dental implants. The recall involves 1,648,273 devices, specifically items IMPAP352G and IMPAP354G. The agency has classified this as a Class II recall.

The reason for the recall is that pouches containing the implants may not have been sealed during packing. This defect could potentially affect the sterility or integrity of the devices.

The affected products were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries. Consumers and healthcare providers should stop using these specific items and contact Biomet 3i, LLC for further instructions or replacement.

The recalled product

Product
Certain Gingihue 15 degree Pre- Angled Post 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: IMPAP352G and IMPAP354G

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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