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U.S. Department of Health and Human Services

Class 2 Device Recall DFINE Vertebral Hydraulic Assemblies

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  Class 2 Device Recall DFINE Vertebral Hydraulic Assemblies see related information
Date Initiated by Firm February 13, 2020
Create Date May 21, 2020
Recall Status1 Terminated 3 on February 26, 2021
Recall Number Z-2067-2020
Recall Event ID 85485
Product Classification Injector, vertebroplasty (does not contain cement) - Product Code OAR
Product 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).
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.
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
801-253-1600
Manufacturer 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.
FDA Determined
Cause 2		 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 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).
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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