Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Misalignment
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin contour 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 describes a functional defect (misalignment) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet 3i, LLC is voluntarily recalling certain Bellatek Encode Healing Abutments, specifically the 3.4mm diameter x 5mm platform x 6mm height model with Reference Number IEHA356. The recall affects units with Lot Number 1228605.
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 the final dental restoration.
The affected products were distributed nationwide and in foreign markets including Australia, Austria, Belgium, China, France, Germany, Italy, Japan, Netherlands, Poland, Spain, and the UK. Healthcare professionals and patients should contact their dental provider or Biomet 3i for further instructions regarding the replacement or management of these specific abutments.
The recalled product
- Product
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356
- 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: 1228605
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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