DFINE recallZ-2068-2020 · Merit Medical Systems, Inc. · initiated Feb 13, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merit Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-2068-2020
- Status
- Terminated
- Initiated by the company
- Feb 13, 2020
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 63
- Product code
- OAR
- 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).
Product description
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).
Code information (models, lots, serial numbers)
Lot number: AAE-1904-01 and UDI: (01)00884450374375(17)240331(10)AAE-1904-01; Lot number: AAE-1908-10 and UDI: (01)00884450374375(17)240731(10)AAE-1908-10.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DFINE® 00884450374375Merit Medical Systems, Inc. · Injector, vertebroplasty (does not contain cement)1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 85485).
- Z-2067-2020 · TerminatedDFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delive…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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