Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment in dental impressions.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a functional defect (rotation/misalignment) rather than a direct physical injury risk, fitting the 'Moderate' criteria for low-risk issues or voluntary precautionary measures without reported harm.
Plain-English summary
Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutments (3.4mm diameter x 3.8mm platform x 3mm height, Reference Number IEHA343). The recall affects Lot Numbers 1228842 and 1230153. These products were distributed nationwide and in several foreign countries, including Australia, Austria, Belgium, China, France, Germany, Italy, Japan, the Netherlands, Poland, Spain, and the UK.
The recall was initiated because the resulting impression or scanned data produced from these specific healing abutment lots may result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment. This defect could impact the accuracy of dental restorations.
Consumers and dental professionals should stop using the affected lots and contact Biomet 3i, LLC for further instructions or replacement.
The recalled product
- Product
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Numbers: 1228842
- 1230153
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.
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