The Recall Desk
ModerateFDA (Devices)·Z-2432-2016·Announced 2016-08-24

Biomet 3i Recalls Locator Replacement Housing Kits Due to Sealing Defects

Biomet 3i is recalling Locator Replacement Housing Kits 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. The hazard involves potential contamination or damage due to unsealed packaging, which is a low-risk contamination issue without reported injuries, fitting the Moderate severity criteria.

Plain-English summary

Biomet 3i, LLC is recalling Locator Replacement Housing Kits (Item: LORHK) used for dental implants. The recall was initiated because pouches containing the products may not have been sealed during the packing process.

The recall covers 1,648,273 units. These products were distributed nationwide in the United States, including Hawaii, Guam, Puerto Rico, and the Virgin Islands, as well as to foreign consignees in numerous countries including Canada, Mexico, and various nations in Europe, Asia, and South America.

Consumers and healthcare providers should stop using the affected Locator Replacement Housing Kits and contact Biomet 3i, LLC for further instructions on how to return or replace the products.

The recalled product

Product
Locator Replacement Housing Kit 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:LORHK

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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