Recall Z-2067-2020 ยท OAR Injector, Vertebroplasty (Does Not Contain Cement)
Merit Medical Systems, Inc.
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
| Date | Feb 13, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Labeling Change Control |
| Action | 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 | 228 |
| Distribution | Worldwide distribution: US Nationwide distribution including in the states of (TX, UT, PA, KY, TX, AR, CA, and PA) which included one (1) government/military consignee in KY; and the countries of (Germany, Switzerland, and New Zealand). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.