Biomet 3i Recalls Dental Implants Due to Unsealed Pouches
Biomet 3i, LLC is recalling Implant Twist Lock TM 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 a packaging defect (unsealed pouches) which is a low-risk contamination or labeling/packaging issue, fitting the Moderate criteria for minor labeling or packaging errors.
Plain-English summary
Biomet 3i, LLC is recalling Implant Twist Lock TM Coping Dental implants. The recall was initiated because pouches containing the devices may not have been sealed during the packing process.
The recall covers 1,648,273 devices. These products were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, and the Virgin Islands, as well as to numerous foreign consignees.
Consumers and healthcare providers should stop using these devices and contact Biomet 3i, LLC for further instructions on how to proceed.
The recalled product
- Product
- Implant Twist Lock TM 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: IIC44.
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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