Biomet 3i Dental Implant Recall for Potential Outer Box Mislabeling
Biomet 3i is recalling 33 dental implants because outer boxes may be mislabeled. The inner trays are correctly labeled, but the error could prevent proper implant placement.
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. The hazard is a labeling error that could prevent proper implant placement, but no injuries or illnesses are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet 3i, LLC is recalling 33 units of the Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L). The recall is due to a potential mislabeling issue on a small number of outer implant boxes. The inner trays containing the actual implants are labeled correctly.
The affected products are identified by Lot number 2012101530, with an expiration date of 2017/12 and Catalog number BNSS513. These products were distributed to the state of Massachusetts and to the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.
If the mislabeling is present and not recognized, the dental implant may not be able to be placed into the osteotomy or seated to the desired depth if placement is attempted. Consumers and healthcare providers should verify the labeling on the inner trays to ensure the correct implant is being used.
The recalled product
- Product
- Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Affected units
- 33
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)
- Lot number: 2012101530 Exp 2017/12 Catalog #: BNSS513
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 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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