The Recall Desk
ModerateFDA (Devices)·Z-2428-2016·Announced 2016-08-24

Biomet 3i Recalls Locator Extra Light Angled Dental Implant Components

Biomet 3i is recalling Locator Extra Light Angled Replacement Males 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 Locator Extra Light Angled Replacement Males 4pk dental implants. The recall was initiated because pouches containing the products may not have been sealed during the packing process.

The recall affects 1,648,273 units of the product, identified by item code LELARM. The products were distributed worldwide, including nationwide in the United States, Hawaii, Guam, Puerto Rico, and the Virgin Islands, as well as to foreign consignees in numerous countries.

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

The recalled product

Product
Locator Extra Light Angled Replacement Males 4pk Dental implants
Manufacturer
Biomet 3i, LLC
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: LELARM

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 →