Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce 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, and the defect involves a functional error (rotation/misalignment) rather than a direct safety 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 IEHA574) due to a defect in the resulting impression or scanned data. The affected abutments are 5mm(D) x 7.5mm(P) x 4mm(H) in size and are associated with Lot Number 1229061.
The recall was initiated because the impression or scanned data produced from these specific lots results in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment. This defect affects the accuracy of the dental work performed using these components.
The products were distributed nationwide and in foreign countries including Australia, Austria, Belgium, China, France, Germany, Italy, Japan, Netherlands, Poland, Spain, and the UK. Consumers and dental professionals should contact Biomet 3i, LLC for further instructions on how to proceed with the recall.
The recalled product
- Product
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
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: 1229061
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.
See all 23 products in this recall →Related recalls
Same manufacturer · Biomet 3i, LLC
See all →- ModerateBiomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- HighBiomet 3i Recalls Misaligned BellaTek Encode Definitive Abutments
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls BellaTek Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls Misaligned BellaTek Dental Abutments
FDA (Devices) · 2020-10-14
Same hazard · misalignment
See all →- ModerateAir dermatomes recalled because the thickness control bar may be misaligned
FDA (Devices) · 2025-12-24
- ModerateDermatome AN units recalled because the thickness control bar may be misaligned
FDA (Devices) · 2025-12-24
- HighQuidel InflammaDry MMP-9 Test: Misaligned Results Window May Cause False Negatives
FDA (Devices) · 2024-05-01
- HighMedical diagnostic test kits recalled due to misaligned results window
FDA (Devices) · 2024-05-01
- HighSuction Canister Liner Recalled for Loss of Suction on Low Settings
FDA (Devices) · 2024-01-24