Biomet 3i Recalls Misaligned BellaTek Encode Definitive Abutments
Biomet 3i, LLC is recalling BellaTek Encode Definitive Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement in patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 prevents the correct placement of a medical device, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Biomet 3i, LLC is recalling seven stand-alone units of BellaTek Encode Definitive Abutments (Reference Numbers: 3DPMSER, 3DPMSERQ). The recall covers specific lot numbers: 8560249-1, 8564285-1, and 8570989-1 for Reference Number 3DPMSER, and 8561588-1, 8561591-1, 8569150-1, and 8570607-1 for Reference Number 3DPMSERQ.
The recall was initiated because the hex of the abutments was misaligned by 30 degrees during manufacturing compared to the provided patient scan data. This defect means the definitive abutment will not seat in the correct orientation upon attempted placement with the patient.
The affected units were distributed in Florida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee, and Virginia. Healthcare providers and patients should contact Biomet 3i, LLC for further instructions regarding the removal or replacement of these devices.
The recalled product
- Product
- BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Affected units
- 7
Distribution
Part of a larger recall action
This product is one of 7 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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