Biostop G Bioresorbable Cement Restrictor

All lots of Biostop G Bioresorbable Cement Restrictor are being removed as a precautionary measure because recent in vitro testing of endotoxin levels from a sample restrictor fully dissolved in solution were calculated at >20,000 endotoxin units (eu)/device over 24 hours, based on restrictor size. This exceeds the recommended value of 20 eu/device over 1 hour as referenced in the current FDA regulatory guidance.

Recall start date: December 21, 2022