Biomet 3i Recalls Titanium Dental Abutments Due to Manufacturing Defect
Biomet 3i is recalling 17 units of Certain Bellatek Titanium Abutments because a manufacturing defect prevents the screw from seating correctly.
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, and the source text describes a manufacturing defect without reporting any specific injuries, illnesses, or fatalities, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Biomet 3i, LLC is recalling 17 units of Certain Bellatek Titanium Abutments 3.4mm (Item Number IEDAT3). These restorative products are intended for use as accessories to endosseous dental implants in the maxilla and mandible.
The recall was initiated because, during manufacturing, the screw stop ledge was not made to the required specification and location within the abutment. This defect results in the screw head seating deeper in the abutment without a positive stop.
The affected units were distributed nationwide in the United States, as well as in Puerto Rico, Canada, and Australia. Consumers and healthcare providers should check their inventory for the specific lot numbers and UDI codes listed in the official recall notice and contact Biomet 3i for instructions on how to return or replace the affected devices.
The recalled product
- Product
- CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
- Manufacturer
- Biomet 3i, LLC
- Affected units
- 17
Distribution
Part of a larger recall action
This product is one of 5 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 5 products in this recall →Related recalls
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- ModerateBiomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment
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- ModerateBiomet 3i Recalls Misaligned BellaTek Dental Abutments
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