Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15292 |
| Brand Name: | Biomet 3i NSK Contra-Angle Torque Driver Kits |
| Model: | Product Codes: NSPDK0, PST1, PSKD0, NCATD0, CATD0, NCATD0C |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | ZimVie Australia Pty Ltd (NZ) 16 Huapai Street Onehunga Auckland 1061 |
| Contact Information: | 0508 122 221 |
| Manufacturer: | Biomet 3i |
| Brand Name: | Biomet 3i Parallel-Wall Implant Navigator Kit |
| Model: | Product Codes: SGKIT, SGTRAY |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | ZimVie Australia Pty Ltd (NZ) 16 Huapai Street Onehunga Auckland 1061 |
| Contact Information: | 0508 122 221 |
| Manufacturer: | Biomet 3i |
| Brand Name: | Biomet 3i Tapered Implant Navigator Kit |
| Model: | Product Code: SGTIKIT, SGTTRAY |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | ZimVie Australia Pty Ltd (NZ) 16 Huapai Street Onehunga Auckland 1061 |
| Contact Information: | 0508 122 221 |
| Manufacturer: | Biomet 3i |
| Brand Name: | Biomet 3i Sterilization Trays |
| Model: | Models: SGTRAY, SGTTRAY, PSDT1 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | ZimVie Australia Pty Ltd (NZ) 16 Huapai Street Onehunga Auckland 1061 |
| Contact Information: | 0508 122 221 |
| Manufacturer: | Implant Innovations Inc |
| Issue: | BIOMET 3i recently conducted revised sterilization validation testing on all commercial surgical kits / trays. During these validations, some models of surgical trays did not meet the Sterility Assurance Level (SAL) of 10-6 in all locations using the previously validated steam gravity sterilization method at twenty (20) minutes (testing was conducted at a half cycle time of ten (10) minutes). These devices, however, were shown to achieve an SAL of 10-6 in all challenged locations using a forty (40) minute exposure (testing was conducted at a half cycle time of twenty (20) minutes). |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 30/8/2013 |
