FDA (Devices) recall action 98399
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Augmentation devices failed bacterial endotoxin testing.
The agency’s own wording, quoted from the enforcement report.
International Life Sciences is recalling the Artelon FlexBand Dynamic Matrix, ref 31057, because the augmentation devices failed bacterial endotoxin testing.
International Life Sciences is recalling the Artelon FlexBand Twist .12, ref TW012, because the augmentation devices failed bacterial endotoxin testing.
International Life Sciences is recalling Artelon FlexBand Plus, refs 41054 and 41057, because the augmentation devices failed bacterial endotoxin testing.