Z-1378-2020Class II

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463

Name: Z-1378-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463
Creator: Biomet 3i, LLC
Published: 2020-01-10
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2020-01-10 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i, LLC began a recall of CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463 on 2020-01-10. FDA classified it as Class II and gives the reason as "Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1378-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-10
Posted: 2020-02-26
Terminated: 2021-08-02
Recalling firm: ZimVie US Corp LLC
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer Biomet issued letter to Distributors, Clinicians via FedX on 1/10/20 stating reason for recall, health risk and action take: Step 1: Quarantine any unused affected products in your inventory for return to Zimmer Biomet Dental. Step 2: Identify any patients currently in your care who have received an affected Certain Encode Healing Abutment with the lot numbers in Table 1. a)If the lot number of the Certain BellaTek Encode Healing Abutment is known: a.If the patient has not yet undergone scanning/impressioning, the affected Certain BellaTek Encode Healing Abutment should be replaced with a new Certain BellaTek Encode Healing Abutment prior to scanning/impressioning. Please contact Zimmer Biomet Dental at the number provided in Step G below for an immediate replacement Certain BellaTek Encode Healing Abutment. b.If the case has already been started and the scan/impression has been sent to a lab, please ask the lab to call BellaTek Customer Service team at the number referenced in Step G below for instructions on how to remediate the case. The lab will not be charged twice for the BellaTek abutment. b)If the lot number of the Certain BellaTek Encode Healing Abutment is unknown, inspect for the product condition using Attachment 2. a.If the referenced product condition is present, please follow the instructions in Step 2a above. The affected healing abutment must be returned to Zimmer Biomet Dental per the below instructions. b.If the referenced condition is not present, reinsert the original healing abutment and release the patient. Complete certificate of Acknowledgement and email to [email protected]. Questions or concerns call the BellaTek Customer Service team at 1-888-800-8045 between 8:00 am and 5:00pm EST, Monday through Friday.
Distribution: Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
Product codes and lots: Lot Numbers: 1228840

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1378-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1366-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1367-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1368-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1369-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1370-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1371-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1372-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1373-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1374-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1375-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1376-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1377-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1378-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1379-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1380-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1381-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1382-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1383-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1384-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1385-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1386-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1387-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26
Z-1388-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26

Product code NHA

K072642Class IIBiomet 3I Dental Abutments and Restorative ComponentsBiomet 3i, Inc. / cleared 2007-12-20

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)