Biomet 3i Recalls IOL Distal Extension Dental Implants Due to Sealing Defects
Biomet 3i, LLC is recalling IOL Distal Extension 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, and the hazard is 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 IOL Distal Extension dental implants. The recall involves 1,648,273 devices that were distributed worldwide, including 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 devices.
Healthcare professionals and consumers who have these specific dental implants should contact Biomet 3i, LLC for further instructions on how to proceed with the recall.
The recalled product
- Product
- IOL Distal Extension Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
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: IOLDE
Distribution
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.
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