| Product Name/Description |
PerFix Plug, PerFix Light Plug, Ventralex Hernia Patch and Bard Mesh
Product codes: 0112750, 0112760, 0112770, 0112780, 0112950, 0112960, 0010301, 0010302, 0010303, 0117050, 0117060, 0117070, 0117080, 0117150, 0117160, 0117170, 0117180, 0112640, 0112650, 0112660, 0112670, 0112680 and 0112720
ARTGs 394752, 400494, 400716, 404318 |
| Reason/Issue |
In 2018, the Therapeutic Goods Administration (TGA) announced regulatory amendments to reclassify medium risk (Class IIB) surgical mesh devices to high risk (Class III). As part of the reclassification exercise, the following changes to the instructions for use (IFU), patient information leaflet (PIL) and/or labelling will be implemented for our reclassified surgical mesh devices.
There is no change in legal manufacturer, actual manufacturing site, product specifications, performance, shelf life, sterilization method, manufacturing process and material of construction.
Products with revised IFU, PIL and/or labelling will be received in stages from mid-2024 onwards |
| Recall Action Instructions |
*PerFix Plug: Change to indications: PerFix Plug is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal and femoral hernias.
*PerFix Light Plug: Change to indications: The PerFix Light Plug is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair of inguinal hernia defects.
*Bard Mesh: Change to indications: Bard Mesh is indicated for the repair of ventral, incisional, umbilical, and inguinal hernias.
Addition of warnings for all: This device is not for the use of repair of pelvic organ prolapse or the use of treatment of stress urinary incontinence.
*Ventralex Hernia Patch: ndication Change: The Ventralex Hernia Patch is indicated for use in the reinforcement of soft tissue deficiencies in the repair of ventral and umbilical hernias.
Addition: Temperature symbols to indicate that the Ventralex Hernia Patch should be stored at or below 25°C.
Action closed on 30/8/2023. |