Merit Medical recalls vertebrae assembly products with incorrect 5-year expiration labels. These products may not function properly or require procedure rescheduling if used beyond their 2-year shelf life.
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.
Merit Medical is recalling vertebrae assembly products that have labels showing a 5-year expiration date instead of the correct 2-year shelf life. Using these products after their actual expiration date could cause the procedure to fail or require rescheduling.
The product's actual shelf life is two years, but the labels show a five-year expiration date. Using the product after its two-year shelf life may cause the procedure to fail or require rescheduling.
Healthcare providers using the StabiliT Vertebral Augmentation System for kyphoplasty procedures are affected. Patients with vertebral fractures treated with this system are at risk if the product expires.
Check for the product names: 'DFINE Vertebral Assemblies' or 'StabiliT Vertebral Augmentation System'. Look for lot numbers AAE-1904-01 or AAE-1908-10 on the labels.
Verify the expiration date on the product label matches the two-year shelf life. If it shows five years, the product is affected.
The product labels show a five-year expiration date instead of the correct two-year shelf life, which could cause procedure failure or rescheduling.
Check the product label for the expiration date. If it shows five years instead of two, contact Merit Medical for guidance.
The recall is for potential procedure failure or rescheduling, not direct injury. The hazard does not involve physical harm to users.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2068-2020 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-2068-2020 from Merit Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
