| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00191-1 |
| Product Name/Description |
Versate Monofilament Mesh, 50x50 cm
Item Code: VTX5050M
ARTG Number: 237409
(Medtronic Australasia - Abdominal hernia surgical mesh, synthetic polymer) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has been made aware of patient reports of abdominal hernia recurrence following hernia repair using Versatex monofilament mesh 50 x 50 cm. The risk is highest in patients who have comorbidities. The majority of these patients have been confirmed to have undergone the Transversus Abdominis Muscle Release (TAR) procedure. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Medtronic is adding the following statement to the Versatex monofilament mesh Instructions for Use so that surgeons are aware of the risks involved in using Versatex monofilament mesh 50x50 cm in TAR procedures: "In case of large abdominal wall defects, use of Versatex monofilament mesh in posterior component separation techniques with transversus abdominis muscle release may lead to a higher risk of hernia recurrence. Versatex monofilament mesh is not recommended for posterior component separation techniques with transversus abdominis muscle release when the mesh is used as a bridging material for the lateral relaxing incisions".
This action has been closed out on 04/02/2019 |
| Contact Information |
02 9857 9000 - Medtronic |