The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue does not affected sales outside the United States (OUS).
The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue does not affected sales outside the United States (OUS).
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Aesculap Implant Systems LLC to request your refund or repair — edit it as you like.
Subject: Recall Z-0623-2018 — Aesculap Implant Systems LLC Aesculap Implant Systems LLC recalls The ELAN 4 Air System is intended Hello, I own a Aesculap Implant Systems LLC recalls The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, that is covered by recall Z-0623-2018 from Aesculap Implant Systems LLC. 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.
