Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19926 |
| Brand Name: | Zimmer UniWallis System Instruments |
| Model: | |
| Affected: | all lots |
| Software version: | |
| Recalling Organisation: | Zimmer Biomet New Zealand Company 210 Khyber Pass Road Grafton Auckland |
| Contact Information: | 09 925 5200 |
| Manufacturer: | Zimmer Spine |
| Issue: | Since the market launch of this product, the instruments were distributed with Instruction for Use related to the method for cleaning and disinfection and for steam sterilisation at health care facilities; however, the method was not adequately validated. Instruments cleaned, disinfected, and sterilised under the former IFU for the UniWallis systems may not be adequately cleaned, disinfected and sterilised resulting in a risk of infection. Manufacturer to provide updated cleaning disinfection and sterilisation instruction for use of UniWallis™ System. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/3/2016 |
