Bellatek Encode Healing Abutment (Biomet 3i) – rotation error (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343
Brand
Biomet 3i, LLC
Lot Codes / Batch Numbers
Lot Numbers: 1228842, 1230153
Products Sold
Lot Numbers: 1228842, 1230153
Biomet 3i, LLC is recalling CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343 due to Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or m. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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 CorporateQuality.PostMarket@zimmerbiomet.com. 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026