DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Ve ...



DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Components:
Units Affected:    63
Recall Date:    Feb 13, 2020
Mfg:
Merit Medical Systems, Inc.
Mfg Country:
United States
Recall ID:    85485
Product ID:    181059
Enforcement Date:    May 27, 2020
Termination Date:    Feb 26, 2021
Last Published:    Feb 26, 2021

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Emert Number:    Z-2068-2020
Emert Status:    Terminated