Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error
Biomet 3i, LLC is recalling specific lots of Bellatek Encode Healing Abutments because they may produce incorrect rotation or margin contour misalignment in scanned data.
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. The hazard involves a manufacturing defect leading to data misalignment, which is a significant quality issue but does not involve reported injuries, fatalities, or high-risk pathogens, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Biomet 3i, LLC is voluntarily recalling certain lots of Bellatek Encode Healing Abutments (Reference Number: IEHA454). The affected product is a 4.1mm diameter x 5mm platform x 4mm height healing abutment. The recall covers specific lot numbers: 1227498, 1228248, 1228639, 1228692, 1227504, 1228863, 1229535, 1229557, and 1228807.
The recall is issued because the resulting impression or scanned data produced from these healing abutments may result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment. This defect could affect the accuracy of dental prosthetics fabricated using the scanned data.
The affected products were distributed nationwide and in foreign countries including Australia, Austria, Belgium, China, France, Germany, Italy, Japan, Netherlands, Poland, Spain, and the UK. Healthcare providers and dental laboratories should stop using the affected lots and contact Biomet 3i, LLC for instructions on how to return or replace the devices.
The recalled product
- Product
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454
- Manufacturer
- Biomet 3i, LLC
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 23 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 23 products in this recall →Related recalls
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