Aesculap recalls Univation X System knee implants (NL488-NL493) due to potential 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 models (Univation X System) because they may loosen over time, potentially requiring additional surgery. This affects patients who received these implants during the specified catalog numbers.
The implants may loosen over time, which could lead to the need for revision surgery. This happens because the implant design might not stay securely in place after initial placement.
Patients who received the Univation X System knee implants with catalog numbers NL488 through NL493 are affected. Those who had these implants during the recall period are most at risk.
Check your implant catalog number on the device packaging or documentation. The affected models have catalog numbers NL488 through NL493.
Look for the catalog number on your implant packaging or documentation to confirm if it's in the affected range (NL488 to NL493).
The recall does not require immediate discontinuation of use. Patients should check their catalog number and contact Aesculap for further instructions.
Contact Aesculap directly to discuss your specific situation and possible next steps for the recall.
The recall states a potential need for revision surgery due to loosening, but it does not indicate immediate risk of serious injury in normal use.
We’ve drafted a message you can send Aesculap to request your refund or repair — edit it as you like.
Subject: Recall Z-2512-2021 — Aesculap Aesculap Hello, I own a Aesculap that is covered by recall Z-2512-2021 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.
