DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System,...

FDA Device Recall #Z-2067-2020 — Class II — February 13, 2020

Recall Summary

Recall Number Z-2067-2020
Classification Class II — Moderate risk
Date Initiated February 13, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Merit Medical Systems, Inc.
Location South Jordan, UT
Product Type Devices
Quantity 228

Product Description

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 for Recall

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.

Distribution Pattern

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).

Lot / Code Information

Lot number: AAD-1801-16 and UDI: (01)00884450374399(17)221231(10)AAD-1801-16; Lot number: AAD-1801-17 and UDI: (01)00884450374399(17)221231(10)AAD-1801-17; Lot number: AAD-1803-01 and UDI: (01)00884450374399(17)230331(10)AAD-1803-01; Lot number: AAD-1804-05 and UDI: (01)00884450374399(17)230430(10)AAD-1804-05; Lot number: AAD-1901-07 and UDI: (01)00884450374399(17)231231(10)AAD-1901-07; Lot number: AAD-1904-04 and UDI: (01)00884450374399(17)240430(10)AAD-1904-04.

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.