Device product

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454

Z-1376-2020

January 10, 2020

Class II

Product summary

Firm: Biomet 3i, LLC
Event: Event 84771
Status: Terminated
Classification: Class II
Quantity: N/A
Official record key: device-enforcement:Z-1376-2020

Official wording

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

Code information: Lot Numbers: 1227498 1228248 1228639 1228692 1227504 1228863 1229535 1229557 1228807

Distribution pattern: Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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