Biomet 3i Recalls Dental Implants Due to Unsealed Pouches
Biomet 3i, LLC is recalling Pick-up 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 packaging integrity (unsealed pouches) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving potential contamination or sterility issues.
Plain-English summary
Biomet 3i, LLC is recalling certain Pick-up Coping Dental implants. The recall is being conducted because the pouches containing the devices may not have been sealed during the packing process. This defect could potentially compromise the sterility or integrity of the packaging.
The recall involves 1,648,273 devices. The affected items include codes IMIC33, IIIC60, IIIC75, IWIP56, IWIP57, IWIP66, and IWIP67. These products 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 contact Biomet 3i, LLC for further instructions on how to handle the recalled devices.
The recalled product
- Product
- Certain Pick-up Coping 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 (6)
- Items: IMIC33
- IIIC60
- IIIC75
- IWIP56
- IWIP57
- IWIP66 and IWIP67.
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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