Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16846 |
| Brand Name: | Anspach E12 Drill System |
| Model: | IFU: 18-0047 Revisions A & B, 18-0074 Revision A, 18-0105 Revision A |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Synthes New Zealand Ltd 507 Mt Wellington Highway Mt Wellington Auckland 1060 |
| Contact Information: | 0800 657 734 |
| Manufacturer: | Anspach Effort Inc |
| Brand Name: | Anspach eMax 2 |
| Model: | IFU: 18-0047 Revisions A & B, 18-0074 Revision A, 18-0105 Revision A |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Synthes New Zealand Ltd 507 Mt Wellington Highway Mt Wellington Auckland 1060 |
| Contact Information: | 0800 657 734 |
| Manufacturer: | Anspach Effort Inc |
| Brand Name: | Anspach iMRI Drill System |
| Model: | IFU: 18-0047 Revisions A & B, 18-0074 Revision A, 18-0105 Revision A |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Synthes New Zealand Ltd 507 Mt Wellington Highway Mt Wellington Auckland 1060 |
| Contact Information: | 0800 657 734 |
| Manufacturer: | Anspach Effort Inc |
| Brand Name: | Anspach eMax 2 Drill System |
| Model: | IFU: 18-0047 Revisions A & B, 18-0074 Revision A, 18-0105 Revision A |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Synthes New Zealand Ltd 507 Mt Wellington Highway Mt Wellington Auckland 1060 |
| Contact Information: | 0800 657 734 |
| Manufacturer: | Anspach Effort Inc |
| Brand Name: | Anspach Micro Max Drill System |
| Model: | IFU: 18-0047 Revisions A & B, 18-0074 Revision A, 18-0105 Revision A |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Synthes New Zealand Ltd 507 Mt Wellington Highway Mt Wellington Auckland 1060 |
| Contact Information: | 0800 657 734 |
| Manufacturer: | Anspach Effort Inc |
| Brand Name: | Anspach Black Max Drill System |
| Model: | IFU: 18-0047 Revisions A & B, 18-0074 Revision A, 18-0105 Revision A |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Synthes New Zealand Ltd 507 Mt Wellington Highway Mt Wellington Auckland 1060 |
| Contact Information: | 0800 657 734 |
| Manufacturer: | Anspach Effort Inc |
| Issue: | Manufacturer identified through internal testing of STERRAD 10A sterilisation process that several Anspach attachments did not achieve the expected sterility assurance level (SAL) of 10-6, and is therefore removing the recommendation to sterilise Anspach product with STERRAD 100S from product labelling. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 18/6/2014 |
