Biomet 3i Recalls Dental Implants Due to Unsealed Pouches
Biomet 3i is recalling DAL-RO Threaded Female 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) which is a low-risk contamination or labeling/packaging issue without reported injuries.
Plain-English summary
Biomet 3i, LLC is recalling DAL-RO Threaded Female Dental implants. The recall is being conducted because pouches containing the devices may not have been sealed during the packing process.
The recall affects 1,648,273 devices. These products were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and to foreign consignees in numerous countries.
Consumers and healthcare providers should stop using these devices and contact Biomet 3i, LLC for further instructions regarding the recall.
The recalled product
- Product
- DAL-RO Threaded Female 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)
- Item: DRAF
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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