Aesculap recalls specific Univation X System Tray knee implant devices due to potential loosening requiring revision surgery. Affected models include NM1090R Navigation Set and others. Contact for return instructions.
Malfunction- loosening of the implant resulting in a potential revision surgery
Aesculap is recalling certain Univation X System Tray knee implant devices because they may loosen over time, requiring revision surgery. This affects specific model numbers and lots of the implants.
The implants may loosen over time, which could lead to the need for revision surgery. This is a potential issue with the implant design or manufacturing process that affects long-term stability.
Patients who received the recalled Univation X System Tray knee implants between the specified model numbers and lots are affected. Those with the NM1090R Navigation Set, NM1092R, NM1095R, NM1096R, or NM1093R implants are most at risk.
Check if your knee implant has the model numbers NM1090R Navigation Set, NM1092R, NM1095R, NM1096R, or NM1093R. The recall covers all lots of these specific implant systems.
Reach out to Aesculap Implant Systems LLC for guidance on next steps for affected implants.
The recall does not require immediate discontinuation of use; however, affected patients should contact Aesculap for further instructions.
The affected models include NM1090R Navigation Set, NM1092R, NM1095R, NM1096R, and NM1093R.
Check the model number on your implant. If it matches NM1090R Navigation Set, NM1092R, NM1095R, NM1096R, or NM1093R, it is part of the recall.
We’ve drafted a message you can send Aesculap to request your refund or repair — edit it as you like.
Subject: Recall Z-2516-2021 — Aesculap Aesculap Hello, I own a Aesculap that is covered by recall Z-2516-2021 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.
