The Recall Desk
LowFDA (Devices)·Z-2453-2016·Announced 2016-08-24

Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

Biomet 3i is recalling Conical EP Pick-Up Coping dental implants 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 due to a packaging-only problem (unsealed pouches) with no reported injuries or illnesses, fitting the criteria for a Low severity score.

Plain-English summary

Biomet 3i, LLC is recalling Conical EP Pick-Up Coping (Hexed) dental implants. The recall involves 1,648,273 devices that were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, and the Virgin Islands.

The reason for the recall is that pouches containing the devices may not have been sealed during packing. This packaging defect could potentially affect the sterility or integrity of the medical devices.

Healthcare professionals and consumers who have these specific dental implants should contact Biomet 3i, LLC for further instructions on how to handle the recalled products.

The recalled product

Product
Conical EP Pick-Up Coping (Hexed) 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:CNRIC

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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