Aesculap recalls Univation X System knee implants (models NO156Z to NO167Z) due to possible loosening requiring revision surgery. Affected patients should contact the manufacturer for details.
Malfunction- loosening of the implant resulting in a potential revision surgery
Aesculap is recalling specific knee implant devices (Univation X System) that may loosen over time, potentially requiring revision surgery. This recall affects patients who received these implants and should contact the manufacturer for guidance.
The implants may loosen over time, which can cause the need for additional surgery to fix the issue. This is a mechanical failure in the implant system that could lead to complications.
Patients who received the Univation X System knee implants (models NO156Z to NO167Z) are affected. Those with these implants are at risk of needing revision surgery if the implant loosens.
Check if your knee implant has a catalog code starting with NO156Z through NO167Z. These models were sold as Univation XF Tibia Cemented implants.
Reach out to Aesculap Implant Systems LLC for specific guidance on your implant model and next steps.
The recall does not require immediate removal; patients should contact Aesculap for advice on whether revision surgery is needed.
The affected models are NO156Z through NO167Z (Univation XF Tibia Cemented implants).
Look for a catalog code on your implant label starting with NO156Z to NO167Z.
We’ve drafted a message you can send Aesculap to request your refund or repair — edit it as you like.
Subject: Recall Z-2514-2021 — Aesculap Aesculap Hello, I own a Aesculap that is covered by recall Z-2514-2021 from Aesculap. 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.