Biomet 3i Dental Implants Recalled for Unsealed Pouches
Biomet 3i is recalling 1.6 million dental implant protection caps 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. The hazard involves potential contamination due to unsealed packaging, which is a moderate risk but does not involve reported injuries or structural defects.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 Provide Protection Cap dental implants. The recall was initiated because the pouches containing the devices may not have been sealed during the packing process.
The affected products include items with codes PPC484, PPC485, PPC654, and PPC655. These devices were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.
Consumers and healthcare providers should stop using the affected devices and contact Biomet 3i for further instructions on how to return or replace the products.
The recalled product
- Product
- Provide Protection 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 (3)
- Item: PPC484
- PPC485
- PPC654 and PPC655.
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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