Z-1377-2020 Class II Terminated
FDA device recall Z-1377-2020 was initiated by Biomet 3I, LLC on Jan 10, 2020 and is designated Class II. 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 The recall status is terminated (terminated Aug 2, 2021).
Recall Details
- Product Type
- Devices
- Report Date
- Mar 4, 2020
- Initiation Date
- Jan 10, 2020
- Termination Date
- Aug 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456
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
Distribution Pattern
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
Code Information
Lot Numbers: 1229560
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1377-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026