Biomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment
Biomet 3i is recalling 35 units of BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.
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 defect prevents correct placement of the device, which is a functional failure, but the source text does not report any injuries, illnesses, or hospitalizations.
Plain-English summary
Biomet 3i, LLC is recalling 35 units of BellaTek Titanium Abutments (Reference Number: IEDAT4) due to a manufacturing defect. The hex of the abutments was misaligned by 30 degrees compared to the provided patient scan data.
This misalignment means the definitive abutment will not seat in the correct orientation when attempted placement is made with the patient. The recall affects units distributed in Florida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee, and Virginia.
Dental professionals should check their inventory for the specific lot numbers listed in the recall notice. If the product is in use or inventory, it should be removed from service and returned to Biomet 3i, LLC for replacement or refund.
The recalled product
- Product
- CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
- Manufacturer
- Biomet 3i, LLC
- Affected units
- 35
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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