Biomet 3i Recalls BellaTek Abutments Due to Manufacturing Misalignment
Biomet 3i is recalling 4 units of BellaTek abutments because the hex was misaligned by 30 degrees, preventing correct placement in patients.
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 device placement, which is a functional failure, but the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Biomet 3i, LLC is recalling 4 units of BellaTek Encode Definitive Abutments (5.0mm, Reference Number IEDAN5). The recall covers specific lot numbers: 8560155-1, 8565718-1, 8565734-1, and 8569780-1.
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.
The affected units were distributed to facilities in Florida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee, and Virginia. Healthcare providers should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Affected units
- 4
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.
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