| 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 |
|
| 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 |