BELLATEK recallZ-0074-2021 · Biomet 3i, LLC · initiated Aug 31, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet 3i, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
FDA root cause category: Device Design
What the company is doing
Zimmer Biomet issued Urgent Medical Device Recall letter dated 8/31/2020 to Dental Labs and Clinicians stating reason for recall, health risk and action to take: Quarantine any affected products (definitive BellaTek abutments/3D printed models) from Attachment 1 in your possession for return to Zimmer Biomet Dental. 2. Identify any clinicians who have received an affected BellaTek Definitive Abutment as identified in Attachment 1. 3. For clinicians that have received an affected BellaTek Definitive Abutment from you, provide a copy of this notice to them along with Attachment 3 for them to complete. B. Certificate of Acknowledgement 1. Complete Attachment 2 Certificate of Acknowledgement and email to [email protected]. Return of product 1. Include a copy of Attachment 2 Certificate of Acknowledgement with any product tobe returned. Using the return shipping label included with this notice, please returnaffected product to the address below. Customer Service will provide additionalshipping labels if needed. Field Action PM Regulatory Compliance Zimmer Biomet 4555 Riverside Dr. Palm Beach Gardens, FL 33410 US D. Retain a copy of the Acknowledgement Form with your recall records in the event of a compliance audit of your facilitys documentation. E. If you have any questions after reviewing this notice, please call or email the Customer Service team at: 1-888-800-8045 or [email protected].
Recall details
- Recall number
- Z-0074-2021
- Status
- Terminated
- Initiated by the company
- Aug 31, 2020
- Recalling firm
- Biomet 3i, LLC
- Quantity
- 2 units
- Product code
- NHA
- FDA submissions
- K052648
- Distribution
- FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
Product description
BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
Code information (models, lots, serial numbers)
Lot Numbers: 8570638-1 UDI: (01)00844868030911(10)8570638-1; 8572781-3 UDI: (01)00844868030911(10)8572781-3
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BELLATEK® EDAT4ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 86402).
- Z-0075-2021 · TerminatedCERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
- Z-0076-2021 · TerminatedCERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
- Z-0077-2021 · TerminatedCERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
- Z-0078-2021 · TerminatedCERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
- Z-0079-2021 · TerminatedCERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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