Z-2068-2020Class II

DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System...

Name: Z-2068-2020 DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System...
Creator: Merit Medical Systems, Inc.
Published: 2020-02-13
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2020-02-13 / Terminated / root cause: labeling and UDI

FDA source

Merit Medical Systems, Inc. began a recall of DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is... on 2020-02-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2068-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-13
Posted: 2020-05-21
Terminated: 2021-02-26
Recalling firm: Merit Medical Systems, Inc.
Product: 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).
Product code: OAR Injector, Vertebroplasty (Does Not Contain Cement)
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.
Root cause tag: labeling and UDI
FDA 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 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.
Quantity in commerce: 63
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2068-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2067-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21
Z-2068-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21

Product code OAR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)