Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because the resulting impression or scanned data may cause incorrect rotation and margin contour misalignment.
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 data misalignment and rotation errors rather than direct physical injury or high-risk pathogens, fitting the criteria for moderate severity where the risk is present but not immediately life-threatening or associated with reported severe injuries.
Plain-English summary
Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutments (4.1mm(D) x 6mm(P) x 4mm(H), Reference Number IEHA464). The recall affects lot numbers 1229063 and 1229569. These products were distributed nationwide and in foreign countries including Australia, Austria, Belgium, China, France, Germany, Italy, Japan, Netherlands, Poland, Spain, and the UK.
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 affects the accuracy of the data used for dental restorations.
The source text does not specify the number of units recalled or report any injuries or illnesses associated with the use of these products. Consumers and dental professionals should contact Biomet 3i, LLC for further instructions on how to handle the affected lots.
The recalled product
- Product
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA464
- Manufacturer
- Biomet 3i, LLC
- Hazard
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: 1229063 1229569
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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