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
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.
Recall Date: Apr 15, 2021
Boston Scientific Corporation
Recall ID: 87709
Product ID: 186811
Enforcement Date: May 5, 2021
Last Published: Apr 23, 2021
Emert Number: Z-1491-2021
Emert Status: Notified