Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error
Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in dental impressions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect poses a risk of harm (incorrect rotation/misalignment) to patients, though no specific injuries are reported in the source text.
Plain-English summary
Biomet 3i, LLC is voluntarily recalling certain Bellatek Encode Healing Abutments, specifically the 4.1mm(D) x 4.1mm(P) x 3mm(H) size with Reference Number IEHA443. The recall affects lot numbers 1227135 and 1228599. The product was distributed nationwide and in several foreign countries, including Australia, Austria, Belgium, China, France, Germany, Italy, Japan, the Netherlands, Poland, Spain, and the UK.
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 affect the accuracy of dental restorations.
Dental professionals and patients who have used these specific lots should contact Biomet 3i, LLC for further instructions on how to proceed. The FDA has classified this as a Class II recall.
The recalled product
- Product
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443
- 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 (2)
- Lot Numbers: 1227135
- 1228599
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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