Official recall notice
FDA DeviceClass IINotable
FDA Recall: Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Q
- Recall date
- 2026-03-18
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Augmentation devices failed bacterial endotoxin testing.
Recommended action
What to do
N/A
Product description
Augmentation devices failed bacterial endotoxin testing.