Biomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment
Biomet 3i is recalling 10 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, and the defect prevents correct placement of the device, representing a moderate risk of procedural failure or injury, but no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Biomet 3i, LLC is recalling 10 units of BellaTek Titanium Abutments (Reference Number: IEDAT5) 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 for placement in a patient. The recall affects 10 units distributed in Florida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee, and Virginia.
Healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to Biomet 3i, LLC according to their instructions.
The recalled product
- Product
- CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
- Manufacturer
- Biomet 3i, LLC
- Affected units
- 10
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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