Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19122 |
| Brand Name: | Ethicon Gynemesh PROLENE Soft (PS) Mesh |
| Model: | GPSL and GPSXL3 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Johnson & Johnson (New Zealand) Limited 507 Mt Wellington Highway Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 922 638 |
| Manufacturer: | Ethicon LLC |
| Brand Name: | Ethicon TVT devices |
| Model: | 810041, 810041A, 810041B, TVTRL, TVTOML |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Johnson & Johnson (New Zealand) Limited 507 Mt Wellington Highway Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 922 638 |
| Manufacturer: | Ethicon Sarl |
| Issue: | Following a TGA review, Johnson & Johnson Medical (JJM) has updated the Instructions for Use (IFU). The key messages include the importance of: - appropriate patient selection - surgeon experience - the need for fully informed patient consent. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/9/2015 |
