Biomet 3i Recalls Dental Implants Due to Unsealed Pouches
Biomet 3i, LLC is recalling Conical EP 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 is a packaging defect (unsealed pouches) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Biomet 3i, LLC is recalling Conical EP Pick-Up Coping (Non-Hexed) dental implants. The recall involves 1,648,273 devices, specifically items CSQ17, CSQ06, and CSQ07. These products were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.
The recall was initiated because pouches containing the devices may not have been sealed during packing. This packaging defect could potentially compromise the sterility or integrity of the dental implants.
Healthcare professionals and consumers who have these specific dental implants should stop using them and contact Biomet 3i, LLC for further instructions on how to proceed.
The recalled product
- Product
- Conical EP Pick-Up Coping (Non-Hexed) 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 (2)
- Item: CSQ17
- CSQ06 and CSQ07.
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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