Biomet 3i Recalls Conical Abutment Pick-up Coping Dental Implants
Biomet 3i, LLC is recalling Conical Abutment 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, and the hazard involves a packaging defect (unsealed pouches) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet 3i, LLC is recalling Conical Abutment Pick-up Coping Dental implants. The recall involves 1,648,273 devices. The agency classifies this as a Class II recall.
The recall was initiated because pouches may not have been sealed during packing. The source text does not specify the exact consequences of the unsealed pouches or report any specific injuries or illnesses.
The affected products were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and Virgin Islands) and numerous foreign countries. The specific item code is MEC33. The source text does not provide specific instructions for consumers on how to handle the recalled devices.
The recalled product
- Product
- Conical Abutment Pick-up Coping Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- 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 (1)
- Item: MEC33.
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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