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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01542-1
Product Name/Description Restorelle DirectFix Anterior, Restorelle DirectFix Posterior and Altis Single Incision Sling

Restorelle DirectFix Anterior
Model/Catalogue Number: 501450
SKU Number: 5014501022
ARTG 190172

Restorelle DirectFix Posterior
Model/Catalogue Number: 501460
SKU Number: 5014601022
ARTG 190172

Altis Single Incision Sling System
Model/Catalogue Number: 519650
SKU Number: 5195601022
ARTG 190173
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 21/12/2017
Responsible Entity Coloplast Pty Ltd
Reason/Issue On November 28, 2017, the Therapeutic Goods Administration (TGA) notified Coloplast of TGA’s decision to remove transvaginal mesh products used to treat Pelvic Organ Prolapse (POP), and single incision mini-slings from the Australian Register of Therapeutic Goods (ARTG), effective January 4, 2018.

The TGA believes there is currently a lack of adequate scientific evidence for it to be satisfied that the risks to patients are outweighed by the benefits of these devices.

Further information can be found on the TGA website.

Following this direction from TGA, Coloplast is recalling all Restorelle DirectFix Anterior, Restorelle DirectFix Posterior, and Altis Single Incision Sling products from the Australian market.

No other Coloplast devices are affected by this recall.
Recall Action Recall
Recall Action Instructions Coloplast is advising hospitals to quarantine any affected product for return to Coloplast. Instructions for product return are provided on the Customer Letter issued to affected customers.

This action has been closed out on the 12/10/2018.
Contact Information 03 9541 1146 - Coloplast