Merit Medical Systems, Inc. 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). Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

On 02/13/2020, the firm notified affected customers using a written notice titled, "URGENT PRODUCT RECALL NOTICE". The letter indicated: (1) Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. (2) Ensure that applicable personnel within your organization are made aware of this field action. (3) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. (4) Please fill out, scan and email the completed Customer Response Form to Customer Service at response email address indicated in the letter. All affected product shipped to you must be accounted for on the CRF. (5) Please immediately return all affected lots in your possession via Federal Express 2nd Day Air using the account number provided in the letter. Please include a copy of the Customer Response Form with the returning product, reference the assigned RMA number on the outside of the box (see Customer Response Form), and ship to ATTN: Receiving & Customer Service at the firm's address listed in the letter. If you have any questions concerning this communication, please don't hesitate to contact your Sales Representative or Customer Service at (801) 208-4381.