Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:15338
Brand Name:BellaTek Zirconia Abutments
Model:EDAZ, EDAZX and ELDExxx
Affected:
Software version:
Recalling Organisation:ZimVie Australia Pty Ltd (NZ)
16 Huapai Street
Onehunga
Auckland 1061
Contact Information:0508 122 221
Manufacturer:Biomet 3i
Issue:The EDAZ abutment faily is curently fracturing at an overall rate of 10.2% - a higher than acceptable rate.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Healthcare Professional
Date Commenced:9/9/2013
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