Biomet 3i Recalls Dental Implant Coping Devices Due to Sealing Defects
Biomet 3i is recalling Implant EP Pick-Up 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, but the hazard is a packaging defect (unsealed pouches) with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 units of Implant EP Pick-Up Coping dental implants. The recall covers specific item codes IIC60, IIC75, WIP55, WIP56, WIP57, WIP66, and WIP67. These devices were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.
The reason for the recall is that the pouches containing the devices may not have been sealed during the packing process. This packaging defect could potentially compromise the sterility or integrity of the dental implants.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this recall. Healthcare providers and patients should contact Biomet 3i, LLC for further instructions regarding the affected devices.
The recalled product
- Product
- Implant EP Pick-Up 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 (6)
- Items: IIC60
- IIC75
- WIP55
- WIP56
- WIP57
- WIP66 and WIP67
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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