Biomet 3i Recalls Dental Implant Impression Coping Due to Sealing Defect
Biomet 3i is recalling IOL Transfer Impression Coping dental implants because pouches may not have been sealed during packing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The hazard is a packaging defect (unsealed pouches) which is a low-risk contamination or labeling/packaging issue without reported injuries, fitting the Moderate criteria.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 IOL Transfer Impression Coping dental implant devices. The recall is due to a manufacturing defect where the pouches containing the devices may not have been sealed during the packing process.
The affected products were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries. The specific product code is IOLTIC.
Consumers and healthcare providers should stop using these devices and contact Biomet 3i, LLC for further instructions on how to return or replace the affected products.
The recalled product
- Product
- IOL Transfer Impression Coping Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Hazard
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: IOLTIC
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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