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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00896-1
Product Name/Description Abut Gold Friction-Fit

Item/Part Number: HLA3G
Lot Numbers: 63395407, 63456331, 63395407, 63510220, 63525249 and 63529116

Item/Part Number: HLA4G
Lot Numbers: 63493320 and 63494469

ARTG Number: 259963
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 9/10/2017
Responsible Entity Biomet 3i Australia Pty Ltd
Reason/Issue Zimmer Biomet has identified that specific dental products have had several parts shipped to the customer with only standard Instruction For Use (IFUs). All the products were missing supplemental IFUs.
There is no significant risk to patients as this issue does not affect any fit, form or function of the product. Nonetheless a delay in surgery could occur while waiting for additional information regarding the product.
Recall Action Recall
Recall Action Instructions Zimmer Biomet is providing users with the supplement IFU's.


This action has been closed out on 25/10/2018
Contact Information 1800 802 457 - Zimmer Biomet Customer Call Centre