ADRIA recalls specific Herniatome surgical tools due to sterilization process not being followed, potentially risking infection. Affected models include 5091749 with lot numbers AD0063/20, AD0313/20, and AD0302/20.
The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
ADRIA is recalling certain Herniatome surgical tools (17G x 9cm Cervical Type, model 5091749) because sterilization cycles were not properly followed. This could lead to infection risks for users.
The sterilization process was not followed correctly, which could mean the tools are not properly disinfected. This increases the risk of infection during surgical procedures.
Surgical professionals who own or use the recalled Herniatome tools are affected. Those who have the specific model and lot numbers are most at risk.
Check for the model number 5091749 on the tool. Affected lots include AD0063/20, AD0313/20, and AD0302/20. The product is a cervical type Herniatome used in surgery.
Look for the model number 5091749 on the Herniatome tool.
Confirm if the tool has one of the affected lot numbers: AD0063/20, AD0313/20, or AD0302/20.
The recall is due to the sterilization process not being followed correctly, which could lead to infection risks.
Check the model number and lot number to see if it's affected. If it is, contact ADRIA for further instructions.
The primary risk is infection due to improper sterilization, but the recall does not indicate immediate danger to users.
We’ve drafted a message you can send ADRIA to request your refund or repair — edit it as you like.
Subject: Recall Z-0146-2022 — ADRIA ADRIA Hello, I own a ADRIA that is covered by recall Z-0146-2022 from ADRIA. 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.