| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00008-1 |
| Product Name/Description |
Tibial Implants
Tibial Implant Size1
Ref. LJU521
Lots # AB3688 – AB5151 – AB4979
Tibial Implant Size 2
Ref.: LJU522
Lot # AB3087
ARTG 134055 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
During a routine surveillance control of tibial implants provided by the Manufacturer’s supplier, some parts were discovered not conform on dimensional aspect, which could compromise adequate assembly between the polyethylene insert and the tibial component. |
| Recall Action |
Recall |
| Recall Action Instructions |
Locate and quarantine the affected devices,
Complete the supplied form to confirm receipt of the recall notification.
The sponsor will contact customers to arrange the return and exchange of affected units.
This action has been closed out on 30/10/2018 |
| Contact Information |
02 9451 2244 - Tornier |