Biomet 3i Recalls Dental Implant Abutments Due to Sealing Defects
Biomet 3i is recalling IOL Abutment and Screw 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. The hazard is a packaging defect (unsealed pouches) which is a low-risk contamination or labeling/packaging issue without reported injuries, fitting the Moderate criteria.
Plain-English summary
Biomet 3i, LLC is recalling IOL Abutment and Screw dental implants. The recall involves 1,648,273 devices, specifically items IOL20T, IOL55T, and IOL70T.
The recall was initiated because pouches may not have been sealed during packing. This defect could potentially affect the sterility or integrity of the 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. Consumers and healthcare providers should stop using these devices and contact Biomet 3i for instructions on return or replacement.
The recalled product
- Product
- IOL Abutment and Screw 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 (2)
- Items: IOL20T
- IOL55T and IOL70T
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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