The Recall Desk
ModerateFDA (Devices)·Z-2415-2016·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.

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, which typically involves a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a packaging defect (unsealed pouches) rather than a direct material defect or reported injury, fitting the Moderate criteria for low-risk contamination or precautionary measures.

Plain-English summary

Biomet 3i, LLC is recalling certain Pick-Up Coping 4.1mm(D) x 5mm(P) dental implants (Item: IIIC12). The recall involves 1,648,273 units from Lot # 1154337 and 1154338.

The recall was initiated because 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 these specific lots and contact Biomet 3i for further instructions.

The recalled product

Product
Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 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 # 1154337 and 1154338

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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