The Recall Desk
LowFDA (Devices)·Z-2414-2016·Announced 2016-08-24

Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

Biomet 3i, LLC is recalling certain 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 classified as FDA Class II, but the hazard is a packaging defect (unsealed pouches) with no reported injuries or illnesses, fitting the criteria for a low-severity packaging-only problem.

Plain-English summary

Biomet 3i, LLC is recalling 1,648,273 units of Pick-Up Coping 4.1mm(D) x 4.1mm(P) dental implants (Item: IIIC41, Lot # 1152085). The recall was initiated because the pouches containing the implants may not have been sealed during the packing process.

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 source text does not specify the exact number of units distributed in each region.

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

The recalled product

Product
Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P) Item: IIIC41 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 # 1152085

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

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Same hazard · packaging defect

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