Biomet 3i Dental Implant Recall Due to Outer Box Mislabeling
Biomet 3i is recalling 51 dental implants because outer boxes may be mislabeled. The implants themselves are correctly labeled, but the error could prevent proper 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 impede proper implant placement, but no injuries or illnesses have been reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet 3i, LLC is recalling 51 units of the Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L). The recall is due to a potential mislabeling issue on the outer implant boxes. The inner tray containing the actual implant is labeled correctly.
The affected products are identified by Lot number 2012111613, with an expiration date of 2017/12 and Catalog number BOPS6510. 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, it could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implant
- Affected units
- 51
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: 2012111613 Exp 2017/12 Catalog #: BOPS6510
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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