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, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutments (Reference Number: IEHA453) distributed nationwide and in several foreign countries. The recall affects Lot Number 1228602.
The recall is being issued because the resulting impression or scanned data produced from these specific healing abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment. This defect may affect the accuracy of dental restorations.
Dental professionals and patients who have used or may have used these specific abutments should contact Biomet 3i, LLC for further instructions on how to proceed.
The recalled product
- Product
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453
- Manufacturer
- Biomet 3i, LLC
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 (1)
- Lot Numbers: 1228602
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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