Biomet 3i Recalls Titanium Dental Implants Due to Unsealed Pouches
Biomet 3i is recalling 1,648,273 titanium 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 issue without reported illnesses or injuries.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 units of Certain Titanium Large Hexed Screw Dental implants. The recall is due to a manufacturing defect where the product pouches may not have been sealed during the packing process.
The affected devices were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, and the Virgin Islands, as well as to numerous foreign consignees. The specific item code for the recalled product is ILRGHT.
Consumers and healthcare providers should stop using these specific dental implants and contact Biomet 3i, LLC for further instructions on how to handle the affected devices.
The recalled product
- Product
- Certain Titanium Large Hexed Screw Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- 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: ILRGHT
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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