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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect that prevents the medical device from seating correctly, posing a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Biomet 3i, LLC is recalling certain BellaTek Titanium Abutments 6.0mm (Reference Number: IEDAT6). The recall is due to a manufacturing defect where 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 upon attempted placement with the patient. The affected units are identified by Lot Number 8562282-1 and UDI (01)00844868031208(10)8562282-1.
The product was distributed in Florida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee, and Virginia. Healthcare providers and patients should contact Biomet 3i, LLC for further instructions regarding the recall.
The recalled product
- Product
- CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
- Manufacturer
- Biomet 3i, LLC
- Affected units
- 1
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 (1)
- Lot Number: 8562282-1 UDI: (01)00844868031208(10)8562282-1
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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