Aesculap recalls Enduro Special Key Tib Lock Ring F1/10mm (product code NP462R) used in knee surgery due to potential key pin damage during assembly. Affected items sold with EnduRo Total Knee System.
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
Aesculap is recalling a special key used in knee surgery implants because it can become nonfunctional during assembly, risking damage to the key pins. This could affect surgical procedures if the key doesn't work properly.
The key can become nonfunctional during assembly of the tibia locking ring due to force applied to the key pins. This might cause the key to fail during surgery, potentially affecting the implant procedure.
Orthopedic surgeons and surgical teams using the Enduro Total Knee System with this specific key. The risk is low as it's a surgical tool that requires careful handling.
Check for the product code NP462R on the key. This key is used with EnduRo Total Knee System implants and has a UDI-DI (GTIN) of 04046963419639.
Verify the key works properly before use during surgery. If it doesn't function, stop using it.
Yes, this key is used during orthopedic implant surgery with the EnduRo Total Knee System.
Stop using it and contact Aesculap for guidance on next steps.
Look for product code NP462R on the key, which is used with EnduRo Total Knee System implants.
We’ve drafted a message you can send Aesculap to request your refund or repair — edit it as you like.
Subject: Recall Z-1391-2022 — Aesculap Aesculap Hello, I own a Aesculap that is covered by recall Z-1391-2022 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.
