Biomet 3i Recalls Misaligned BellaTek Titanium Abutments
Biomet 3i is recalling BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, 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, but the source text describes a manufacturing defect that prevents correct placement without explicitly reporting injuries, hospitalizations, or deaths. This aligns with a moderate severity rating for a defect that compromises function but lacks reported harm.
Plain-English summary
Biomet 3i, LLC is recalling two units of the BellaTek Titanium Abutment 4.1mm (Reference Number: EDAT4). 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 manufacturing defect means the definitive abutment will not seat in the correct orientation upon attempted placement with the patient. The affected units were distributed to facilities in Florida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee, and Virginia.
The specific lot numbers involved are 8570638-1 and 8572781-3. Healthcare providers and patients should check their inventory or records for these specific reference numbers and lot codes to identify affected units.
The recalled product
- Product
- BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
- Manufacturer
- Biomet 3i, LLC
- Affected units
- 2
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 (2)
- Lot Numbers: 8570638-1 UDI: (01)00844868030911(10)8570638-1
- 8572781-3 UDI: (01)00844868030911(10)8572781-3
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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FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
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