FDA Recalls BIOSTOP G Cement Restrictor Due to Elevated Endotoxin Levels
DePuy Ireland is recalling all lots of BIOSTOP G Bioresorbable Cement Restrictor because endotoxin levels exceeded FDA regulatory guidance. Endotoxins can cause inflammatory responses, from mild fever to potential organ damage.
- Product
- BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20)
- Category
- Medical Device
- Distribution
- Distributed nationwide