The Recall Desk
LowFDA (Devices)·Z-2430-2016·Announced 2016-08-24

Biomet 3i Recalls Locator Light Retention Dental Implant Components

Biomet 3i is recalling Locator Light Retention Replacement Males because pouches may not have been sealed during packing.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a packaging-only problem (unsealed pouches) with no reported injuries or illnesses, fitting the 'Low' severity criteria for cosmetic or packaging issues.

Plain-English summary

Biomet 3i, LLC is recalling Locator Light Retention Replacement Males 4pk dental implants. The recall is due to a packaging defect where pouches may not have been sealed during the packing process.

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

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

The recalled product

Product
Locator Light Retention 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:LLRMS

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 →