The Recall Desk
ModerateFDA (Devices)·Z-2421-2016·Announced 2016-08-24

Biomet 3i Recalls Gold-Tite Square Uniscrew Dental Implants Due to Sealing Issues

Biomet 3i is recalling Gold-Tite Square Uniscrew dental implants because pouches may not have been sealed during packing. The recall affects 1,648,273 units distributed worldwide.

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

Plain-English summary

Biomet 3i, LLC is recalling Gold-Tite Square Uniscrew dental implants (Item: UNISG) because the pouches containing the devices may not have been sealed during the packing process. The recall covers 1,648,273 units, specifically those from Lot # 1152611 and 1153193.

The affected products were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries. The FDA has classified this as a Class II recall.

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

The recalled product

Product
Gold-Tite Square Uniscrew Item: UNISG 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 # 1152611 and 1153193

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 →

Related recalls

Same manufacturer · Biomet 3i, LLC

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Same hazard · packaging defect

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