Biomet 3i Recalls Certain Bellatek Titanium Abutments Due to Manufacturing Defect
Biomet 3i is recalling 6 units of Certain Bellatek Titanium Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.
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 defect creates a risk of harm to the implant structure, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Biomet 3i, LLC is recalling 6 units of Certain Bellatek Titanium Abutments 3.4mm (Item Number IIAT3). These restorative products are intended for use as accessories to endosseous dental implants in the maxilla and mandible.
The recall is due to a manufacturing defect where the screw stop ledge was not made to the correct specification and location within the abutment. This 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. Specific lot numbers and UDI codes for the affected units are listed in the official recall documentation.
The recalled product
- Product
- CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - 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
- 6
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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