The Recall Desk
ModerateFDA (Devices)·Z-2407-2016·Announced 2016-08-24

Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

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

Plain-English summary

Biomet 3i, LLC is recalling certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) dental implants (Item: IWTH54). The recall involves 1,648,273 units from Lot # 1153081. These products 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 defect could potentially compromise the sterility or integrity of the medical device.

Healthcare professionals and patients who have received these specific dental implants should contact Biomet 3i, LLC for further instructions on how to proceed. The FDA has classified this as a Class II recall.

The recalled product

Product
Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 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 # 1153081

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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