FDA Medical Device Recalls (openFDA)
Biomet 3i, LLC: CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
- Recall number
- Z-0079-2021
- Recalling firm
- Biomet 3i, LLC
- Product
- CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
- Status
- Terminated
- Initiated
- 2020-08-31
- Posted
- not on file
- Terminated
- 2022-07-06
- Reason
- 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
- Root cause
- Device Design
- Action
- 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 orporateQuality.PostMarket@zimmerbiomet.com. 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 DentalCSDigital@ZimmerBiomet.com.
- Quantity
- 1 unit
- Distribution
- FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
- Lot, serial or model codes
- Lot Number: 8562282-1 UDI: (01)00844868031208(10)8562282-1
- 510(k) numbers
- ["K052648"]
- PMA numbers
- not on file
- Product code
- NHA
- Firm FEI
- 1038806
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28