Biomet 3i Recalls Conical EP Healing Caps Due to Sealing Defects
Biomet 3i, LLC is recalling Conical EP Healing Caps for 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 source text explicitly states no illnesses or injuries have been reported. The hazard is a packaging defect (unsealed pouches) which is a low-risk contamination or labeling/packaging issue, fitting the Moderate criteria for voluntary precautionary recalls or minor defects without reported harm.
Plain-English summary
Biomet 3i, LLC is recalling Conical EP Healing Caps for dental implants. The recall involves 1,648,273 devices, specifically items CS250, CS260, and CS270. The reason for the recall is that pouches may not have been sealed during packing.
The affected products were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries. The source text does not specify a particular date range for the distribution or the recall initiation.
Consumers and healthcare providers should stop using these specific healing caps and contact Biomet 3i, LLC for further instructions or a replacement. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Conical EP Healing Cap 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: CS250
- CS260 and CS270.
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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