Biomet 3i Recalls Dental Implants Due to Unsealed Pouches
Biomet 3i is recalling 1.6 million Temporary Non-Hexed Cylinder 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 or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 units of Temporary Non-Hexed Cylinder Dental Implants. The recall involves items ITCS42, WTCS52, and WTCS62. The agency classifies this as a Class II recall.
The reason for the recall is that pouches may not have been sealed during packing. The devices were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.
Consumers and healthcare providers should stop using the affected devices and contact Biomet 3i, LLC for further instructions.
The recalled product
- Product
- Temporary Non-Hexed Cylinder 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)
- Item: ITCS42
- WTCS52 and WTCS62.
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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