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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