The Recall Desk
ModerateFDA (Devices)·Z-2408-2016·Announced 2016-08-24

Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

Biomet 3i is recalling specific dental implant abutments because their packaging 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 involves a packaging defect (unsealed pouches) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Biomet 3i, LLC is recalling certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H) dental implants, identified by Item IWTH564 and Lot # 1150836. The recall involves 1,648,273 units that were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.

The recall was initiated because the pouches containing the implants may not have been sealed during the packing process. This packaging defect could potentially compromise the sterility or integrity of the medical devices.

Healthcare professionals and consumers who have these specific dental implants should contact Biomet 3i, LLC for instructions on how to return the product or obtain a replacement. The recall is classified as Class II by the FDA.

The recalled product

Product
Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H) Item: IWTH564 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 # 1150836

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

See all →

Same hazard · packaging defect

See all →