The Recall Desk
ModerateFDA (Devices)·Z-2443-2016·Announced 2016-08-24

Biomet 3i Recalls Standard Abutment Dental Implants Due to Sealing Defects

Biomet 3i, LLC is recalling Standard Abutment Dental implants 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, but the hazard is a packaging defect (unsealed pouches) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Biomet 3i, LLC is recalling Standard Abutment Dental implants (items AB200, AB300, AB400, AB500, and AB700) because the pouches containing the devices may not have been sealed during the packing process. The recall involves 1,648,273 devices.

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 FDA has classified this recall as Class II.

Healthcare professionals and consumers should stop using the affected devices and contact Biomet 3i, LLC for further instructions on how to return or replace the products.

The recalled product

Product
Standard Abutment 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 (4)

  • Item: AB200
  • AB300
  • AB400
  • AB500 and AB700.

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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