Biomet 3i Recalls Misaligned BellaTek Dental Abutments
Biomet 3i is recalling 9 units of BellaTek Encode Definitive Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct 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 defect prevents correct placement of the dental abutment, which is a functional failure but does not involve a high-risk pathogen, structural vehicle defect, or reported hospitalizations, fitting the Moderate criteria.
Plain-English summary
Biomet 3i, LLC is recalling 9 units of BellaTek Encode Definitive Abutments (4.1mm, Reference Number: IEDAN4). The recall affects specific lot numbers distributed to facilities in Florida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee, and Virginia.
The recall was initiated because the hex of the abutments was misaligned by 30 degrees during manufacturing compared to the provided patient scan data. This defect means the definitive abutment will not seat in the correct orientation when attempted placement is performed on the patient.
Healthcare providers and patients should check their inventory and patient records for the affected lot numbers. If the product is identified, it should be removed from use and returned to Biomet 3i, LLC according to their instructions.
The recalled product
- Product
- CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
- Manufacturer
- Biomet 3i, LLC
- Affected units
- 9
Distribution
Part of a larger recall action
This product is one of 7 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.
See all 7 products in this recall →Related recalls
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