Biomet 3i Recalls Dental Implants Due to Unsealed Pouches
Biomet 3i is recalling 1.6 million dental implant abutments because some 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 is a packaging defect (unsealed pouches) which is a low-risk contamination or precautionary issue without reported injuries.
Plain-English summary
Biomet 3i, LLC is recalling certain Conical 17 degree Angled Abutment dental implants (items IAC4217 and IAC4417). The recall involves 1,648,273 devices that were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.
The recall was initiated because the pouches containing the devices may not have been sealed during packing. This packaging defect could potentially compromise the sterility or integrity of the dental implants.
Consumers and healthcare providers should stop using these specific dental implant abutments and contact Biomet 3i, LLC for further instructions on how to return or replace the affected products.
The recalled product
- Product
- Certain Conical 17 degree Angled Abutment 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)
- Items: IAC4217 and IAC4417
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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