Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18625 |
| Brand Name: | Zimmer iASSIST Tibial Alignment Guide |
| Model: | 20-8011-013-00 |
| Affected: | 120265, 120793, 120794, 130135, 130539 |
| Software version: | |
| Recalling Organisation: | Zimmer Biomet New Zealand Company 210 Khyber Pass Road Grafton Auckland |
| Contact Information: | 09 925 5200 |
| Manufacturer: | Zimmer CAS |
| Issue: | Zimmer 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. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 9/6/2015 |
