Z-0076-2021Class II

CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5

Name: Z-0076-2021 CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
Creator: Biomet 3i, LLC
Published: 2020-08-31
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2020-08-31 / Terminated / root cause: design

FDA source

Biomet 3i, LLC began a recall of CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5 on 2020-08-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0076-2021
Classification: Class II
Status: Terminated
Initiated: 2020-08-31
Posted: 2020-10-08
Terminated: 2022-07-06
Recalling firm: ZimVie US Corp LLC
Product: CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: 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 tag: design
FDA 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 [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].
Quantity in commerce: 4 units
Distribution: FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
Product codes and lots: Lot Numbers: 8560155-1 8565718-1 8565734-1 8569780-1 UDI: (01)00844868031154(10)8560155-1 (01)00844868031154(10)8565718-1 (01)00844868031154(10)8565734-1 (01)00844868031154(10)8569780-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0076-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0073-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08
Z-0074-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08
Z-0075-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08
Z-0076-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08
Z-0077-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08
Z-0078-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08
Z-0079-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08

Product code NHA

K052648Class IIModification to 3I Patient-Specific Dental Abutments and Overdenture BarsImplant Innovations, Inc. / cleared 2005-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)