International Life Sciences recalls Artelon FlexBand Dynamic Matrix Ref: 31057
Augmentation devices failed bacterial endotoxin testing.
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 37–48 of 101 recalls
Augmentation devices failed bacterial endotoxin testing.
Lack of 510K clearance
Lack of 510K clearance
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference.…
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference.…
Due to a manufacturing issue and electrical grounding of systems.
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial trea…
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.