Biomet 3i Recalls Titanium Abutments Due to Manufacturing Defect
Biomet 3i is recalling 49 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 does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity rating.
Plain-English summary
Biomet 3i, LLC is recalling 49 units of Certain Bellatek Titanium Abutment 3.4mm (Item Number ILDAT3). These medical devices are intended for use as accessories to endosseous dental implants in the upper and lower jaws.
The recall was initiated because the screw stop ledge was not made to specification and location during manufacturing. This defect results in the screw head seating deeper in the abutment without a positive stop.
The affected units were distributed nationwide, as well as in Puerto Rico, Canada, and Australia. Patients and dental professionals should contact their dental provider or Biomet 3i for instructions on how to address the affected devices.
The recalled product
- Product
- CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - 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
- 49
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
Same manufacturer · Biomet 3i, LLC
See all →- ModerateBiomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- HighBiomet 3i Recalls Misaligned BellaTek Encode Definitive Abutments
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- ModerateBiomet 3i Recalls Misaligned BellaTek Titanium Abutments
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls BellaTek Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
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