Biomet 3i Recalls DAL-RO Abutment Dental Implants Due to Sealing Defects
Biomet 3i, LLC is recalling DAL-RO 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 source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet 3i, LLC is recalling DAL-RO Abutment dental implants (items DRH20, DRH40, and DRH60) because the pouches containing the devices may not have been sealed during the packing process. The recall covers 1,648,273 devices distributed worldwide, including the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.
The FDA has classified this as a Class II recall. The source text does not report any illnesses, injuries, or deaths associated with this defect. Consumers and healthcare providers should stop using the affected products and contact Biomet 3i, LLC for further instructions on returns or replacements.
The recalled product
- Product
- DAL-RO Abutment 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 (2)
- Items: DRH20
- DRH40 and DRH60
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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