UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product ...



UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.M0068318220 Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal. Note: The UpsylonTM Y Mesh Kit consists of UpsylonTM Y Mesh and ColpassistTM Vaginal Positioning Device packaged and sterilized separately and then combined into a kit carton. This removal does not affect the UpsylonTM Y Mesh component of the kit, however, since the Colpassist device component is impacted, the entire UpsylonTM Y Mesh kit is being removed.
Components:
Recall Date:    Apr 15, 2021
Mfg:
Boston Scientific Corporation
Mfg Country:
United States
Recall ID:    87709
Product ID:    186811
Enforcement Date:    May 5, 2021
Last Published:    Apr 23, 2021

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Emert Number:    Z-1491-2021
Emert Status:    Notified