Biomet 3i Recalls Certain Bellatek Tin Abutments Due to Manufacturing Defect
Biomet 3i is recalling 2 units of Bellatek Tin Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.
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 score.
Plain-English summary
Biomet 3i, LLC is recalling 2 units of CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3. These products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandilla.
The recall was initiated because, during manufacturing, the screw stop ledge was not made to specification and location within the abutment. This defect results in the screw head seating deeper in the abutment with no positive stop.
The affected units were distributed nationwide and in Puerto Rico, Canada, and Australia. The specific lot numbers are 8442561-2 and 8442561-3. Consumers and healthcare providers should check their inventory for these specific item numbers and lot codes.
The recalled product
- Product
- CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - 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
- 2
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.
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