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Type of Product Medical Device
TGA Recall Reference RC-2019-RN-00681-1
Product Name/Description Xenform Soft Tissue Repair Matrix and Pinnacle LITE Pelvic Floor Repair Kit, Posterior

All Batch Numbers

Xenform Soft Tissue Repair Matrix:

Tissue Repair Matrix - 2cm x 7cm
UPN: M0068302410

Tissue Repair Matrix - 4cm x 7cm
UPN: M0068302430

Tissue Repair Matrix 6cm x 10cm
UPN: M0068302450

Tissue Repair Matrix 8cm x 12cm
UPN: M0068302470

ARTG: 174878

Pinnacle LITE Pelvic Floor Repair Kit, Posterior
UPN: M0068318150

ARTG: 246992 - Cancelled
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 2/05/2019
Responsible Entity Boston Scientific Pty Ltd
Reason/Issue In August 2017, supply of Pinnacle LITE Pelvic Floor Repair Kit was discontinued from the Australian market. In December 2017, the indications for use for Xenform Soft Tissue Repair Matrix were amended to remove the indication for transvaginal placement of pelvic organ prolapse.

On Tuesday, April 16, 2019, the United States Food and Drug Administration ( US FDA) ordered all manufacturers of surgical mesh for transvaginal repair of pelvic organ prolapse to stop selling products immediately and withdraw all products from the US market. The US FDA does not believe sufficient clinical evidence is available to assure the benefits of these devices outweigh their probable risks. As a result, Boston Scientific is also withdrawing these products in Australia.

This action is being undertaken to ensure any inventory remaining at customer sites with the indication for transvaginal placement is returned to Boston Scientific.

No other Boston Scientific products are impacted by this action.
Recall Action Recall
Recall Action Instructions Boston Scientific is advising hospitals to immediately discontinue use of and segregate affected product. The devices should be stored in a secure location for return to Boston Scientific.
For customers with impacted product, please package them in an appropriate shipping box and contact the local Boston Scientific Sales Representative, to arrange return.

This action has been closed out on 14/04/2020
Contact Information 02 8063 8144 - Renee Cotta