| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00482-1 |
| Product Name/Description |
Tibial Alignment Guide – iAssist Knee System
Tibial Alignment Guide Part Number: 20-8011-013-00
Lot Numbers: 120265, 120793, 120794, 130135, 130539
ARTG Number: 205936 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
Based upon complaint investigation, Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use. The bending or breakage of the spikes is due to a stress riser at the junction of the spike and the main body of the instrument in combination with the presence of repeated high cyclic bending stresses from the impaction method utilized. These stresses are significantly increased when the proper steps of the surgical technique are not followed. Although unlikely, if a spike breaks and goes unobserved, there is the possibility of a spike being left in the surgical site. There have not been any complaints for this instrument associated with a spike being left in a patient. Product manufactured after May 2014 is not affected as they have a different assembly method of the spike that reduces the risk of fatigue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zimmer is notifying hospitals and surgeons of this issuing and providing instructions on how to minimise the risk of bending or breaking. Further action will be carried out by Stryker pending the availability of replacement units. This action has been closed-out on 07/06/2016. |
| Contact Information |
02 9483 5400 Zimmer |