Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches
Biomet 3i, LLC is recalling 1,648,273 Implant EP Twist Lock Coping 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. The hazard involves potential packaging failure (unsealed pouches) which is a low-risk contamination or packaging issue without reported injuries, fitting the Moderate criteria for minor labeling/packaging errors or low-risk contamination.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 units of Implant EP Twist Lock Coping Dental Implants. The recall was initiated because 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 IWIT67.
Consumers and healthcare providers should stop using these specific dental implants and contact Biomet 3i, LLC for further instructions on how to return or replace the affected devices.
The recalled product
- Product
- Certain Implant EP Twist Lock TM Coping Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
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: IWIT67
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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