Aesculap recalls specific Univation X System knee implants due to potential loosening that may require revision surgery. Affected models include NL494 to NL499 with 11mm size.
Malfunction- loosening of the implant resulting in a potential revision surgery
Aesculap is recalling certain Univation X System knee implants that could loosen over time, potentially requiring additional surgery. This risk affects patients who have received these specific implant models.
The implants may loosen over time, which could lead to the need for revision surgery. This happens because the implant's design might not hold securely in the knee joint under long-term use.
Patients who received the Univation X System knee implants with catalog numbers NL494 through NL499 (11mm size) are most at risk. These implants were sold to patients during the product's active use period.
Check your implant's catalog number on the packaging or device label. The affected models are NL494 to NL499 with a 11mm size.
Look for the catalog number on your implant's packaging or device label to confirm if it is affected.
The recall does not require immediate discontinuation; patients should check their implant catalog number to determine if they are affected.
The recall does not specify a remedy, so contact Aesculap directly for guidance on next steps.
Affected implants have catalog numbers NL494 through NL499 with a 11mm size. Check your implant's packaging or label for this information.
We’ve drafted a message you can send Aesculap to request your refund or repair — edit it as you like.
Subject: Recall Z-2513-2021 — Aesculap Aesculap Hello, I own a Aesculap that is covered by recall Z-2513-2021 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.
