Biomet 3i Recalls Temporary Dental Implants Due to Unsealed Pouches
Biomet 3i is recalling 1,648,273 temporary dental implants because their packaging 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 precautionary recall.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 units of certain temporary non-hexed cylinder dental implants. The recall is being conducted because the pouches containing the devices may not have been sealed during the packing process.
The affected products include items with codes IITCS42, IWTCS52, and IWTCS62. These devices were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries.
Consumers and healthcare providers should stop using the affected implants and contact Biomet 3i, LLC for further instructions on how to return or replace the devices.
The recalled product
- Product
- Certain Temporary Non-Hexed Cylinder 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 (2)
- Items: IITCS42
- IWTCS52 and IWTCS62.
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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