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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The defect involves data accuracy (rotation/misalignment) rather than direct physical injury or contamination, fitting the Moderate severity criteria for low-risk functional defects without reported harm.
Plain-English summary
Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutments (Reference Number: IEHA566) due to a defect in the resulting impression or scanned data. The affected lots are 1228701, 1230640, and 1232762. The product is a 5mm(D) x 6mm(P) x 6mm(H) healing abutment.
The recall is issued because the impression or scanned data produced from these specific 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.
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 professionals and patients should contact Biomet 3i, LLC for further instructions on how to manage the recalled devices.
The recalled product
- Product
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566
- 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: 1228701 1230640 1232762
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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