Recall Z-2067-2020— Merit Medical Systems, Inc.

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2020-02-13, terminated 2021-02-26. FDA's recall record names no specific 510(k) clearance for this event. Product: DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - 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).. Reason: Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five (5) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a delay in procedure or the need for the procedure to be rescheduled..

Recalling firm

Merit Medical Systems, Inc.

Classification

Class II

Status

Terminated

Initiated

2020-02-13

Terminated

2021-02-26

Firm location

South Jordan, UT, United States

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