Merit Medical recalls hydraulic assemblies for StabiliT Vertebral Augmentation System due to incorrect expiration dates. Products may expire prematurely, causing procedure delays or needing rescheduling.
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 hydraulic assemblies for the StabiliT Vertebral Augmentation System because the expiration date on labels is five years instead of two. This could lead to the product not working properly or requiring a procedure to be rescheduled.
The hydraulic assemblies have an incorrect expiration date printed on labels. The product is only supposed to last two years, but the labels show a five-year expiration. Using the product beyond its two-year shelf life may cause it to not function properly or require rescheduling the procedure.
Patients undergoing kyphoplasty procedures for vertebral fractures may be affected. Medical professionals using the StabiliT system are most at risk of procedure delays.
Check for lot numbers AAD-1801-16, AAD-1801-17, AAD-1803-01, AAD-1804-05, or AAD-1901-07 and AAD-1904-04 on the product labels. The product is sold under the StabiliT Vertebral Augmentation System.
Look for lot numbers AAD-1801-16, AAD-1801-17, AAD-1803-01, AAD-1804-05, AAD-1901-07, or AAD-1904-04 on the product labels.
The labels show a five-year expiration date, but the product is only valid for two years.
Using the product beyond its two-year shelf life may cause it to not function properly or require rescheduling the procedure.
The recall does not specify a return or replacement remedy.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2067-2020 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-2067-2020 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.
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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.
