The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2409-2016·Announced 2016-08-24

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

Biomet 3i is recalling specific Gingihue dental implants because pouches may not have been sealed during packing.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The defect is a packaging issue (unsealed pouches) without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or precautionary recalls.

Plain-English summary

Biomet 3i, LLC is recalling certain Gingihue 15 degree Angled Post dental implants (Item: IMPAP32G) due to a manufacturing defect. The recall involves 1,648,273 units of the product.

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

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 the affected implants and contact Biomet 3i, LLC for further instructions.

The recalled product

Product
Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G 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)

  • Lot # 1154709-5

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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