Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Misalignment
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.
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, and the defect involves data misalignment rather than a direct physical hazard like infection or injury, fitting the criteria for moderate severity.
Plain-English summary
Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutments (Reference Number: IEHA344) due to a defect in the data they produce. The recall covers specific lot numbers: 1228885, 1229618, 1230155, and 1230308.
The defect causes the impression or scanned data produced from these healing abutments to result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment. This issue may affect the accuracy of dental restorations created using the affected components.
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 providers and patients should contact Biomet 3i for further instructions regarding the recall.
The recalled product
- Product
- CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344
- 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: 1228885 1229618 1230155 1230308
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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