Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19551 |
| Brand Name: | Biomet 3i Bellatek Encode Healing Abutment |
| Model: | EHA343, EHA344, EHA346, EHA348, EHA353, EHA354, EHA356, EHA358, EHA443, EHA444, EHA446, EHA448, EHA453, EHA454, EHA456, EHA458, EHA463, EHA464, EHA466, EHA468, EHA473, EHA474, EHA476, EHA478, EHA553, EHA554, EHA556, EHA558, EHA563, EHA564, EHA566, EHA568, |
| Affected: | Expiry dates between Nov-2015 and Nov-2020 |
| Software version: | |
| Recalling Organisation: | ZimVie Australia Pty Ltd (NZ) 16 Huapai Street Onehunga Auckland 1061 |
| Contact Information: | 0508 122 221 |
| Manufacturer: | Implant Innovations Inc |
| Issue: | Through investigation, BIOMET 3i determined that a limited number of product pouches may not have been sealed during packaging. The occurrence rate to date of a pouch not being sealed during packaging is approximately 0.008%. In the event the product pouch is unsealed, the sterility of the product contained within the pouch cannot be assured and/or the component may be missing. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 11/12/2015 |
