FDA Medical Device Recalls (openFDA)
Biomet 3i, LLC: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
- Recall number
- Z-1369-2020
- Recalling firm
- Biomet 3i, LLC
- Product
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
- Status
- Terminated
- Initiated
- 2020-01-10
- Posted
- not on file
- Terminated
- 2021-08-02
- Reason
- 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
- 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 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.
- Quantity
- not on file
- Distribution
- Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
- Lot, serial or model codes
- Lot Numbers: 1228667
- 510(k) numbers
- ["K072642"]
- 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