Biomet 3i Recalls Dental Implants Due to Unsealed Pouches
Biomet 3i, LLC is recalling 1,648,273 Healing 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, and the hazard involves a packaging defect (unsealed pouches) without reported injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 units of Healing Abutment Dental Implants. The recall is being conducted because the product pouches may not have been sealed during the packing process. The affected items include codes THA42, THA43, THA44, THA46, and THA48.
The recall covers devices distributed worldwide, including nationwide in the United States and its territories (Hawaii, Guam, Puerto Rico, and Virgin Islands), as well as numerous foreign countries. The source text does not specify a particular date range for the distribution of these units.
Consumers and healthcare providers should contact Biomet 3i, LLC for further instructions regarding the return or replacement of these devices. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Healing Abutment Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Hazard
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)
- Items: THA42
- THA43
- THA44
- THA46 and THA48.
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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