Aesculap recalls Univation X System knee implants (models NO180Z to NO189Z) due to potential loosening causing 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 Univation X System knee implants that may loosen over time, requiring revision surgery. This recall affects patients who received these implants between 2019 and 2023.
The implants can loosen due to normal use over time, which may require revision surgery. This is a mechanical issue with the implant design that affects long-term stability.
Patients who received the Univation X System knee implants (models NO180Z to NO189Z) between 2019 and 2023 are most at risk. These implants are cemented to the femur and may loosen over time.
Check if your implant has a catalog code starting with NO180Z through NO189Z. These models were sold between 2019 and 2023.
Reach out to Aesculap Implant Systems LLC for details about your specific implant model and next steps.
No, the recall does not require immediate removal. Patients should contact Aesculap for guidance on next steps.
The recall states a potential need for revision surgery due to loosening, but does not mention immediate injury risks.
Check if your implant has a catalog code starting with NO180Z through NO189Z, which were sold between 2019 and 2023.
We’ve drafted a message you can send Aesculap to request your refund or repair — edit it as you like.
Subject: Recall Z-2515-2021 — Aesculap Aesculap Hello, I own a Aesculap that is covered by recall Z-2515-2021 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.