Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error
Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour misalignment in scanned 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 source text describes a functional defect (rotation error) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutments (5mm(D) x 6mm(P) x 4mm(H), Reference Number IEHA564). The recall affects specific lot numbers: 1228628, 1230644, 1232164, 1232542, and 1232758.
The recall was initiated because the resulting impression or scanned data produced from these healing abutment lots results in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment. This defect may affect 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 providers and consumers should stop using the affected lots and contact Biomet 3i, LLC for further instructions.
The recalled product
- Product
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
- 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: 1228628 1230644 1232164 1232542 1232758
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 · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02