Aesculap recalls ENNOVATE MIS Removal Key Short (SZ380R) due to risk of spinal fixation arm fracture if 90-degree angle not met during use. Affected users should contact for details.
Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system.
Aesculap recalls its ENNOVATE MIS REMOVALKEY SHORT (product code SZ380R) because it can fracture or break the spinal fixation arm if the 90-degree angle isn't maintained when using the removal key with spinal fixation systems. This poses a risk of serious injury during spinal surgery procedures.
The spinal fixation arm can fracture or break if the removal key is not used at a precise 90-degree angle with the spinal fixation system. This risk occurs during the removal process of spinal hardware, potentially causing serious injury to the patient.
Surgical teams and medical professionals who use this removal key during spinal procedures are most at risk. Patients undergoing spinal surgery with this device may also be affected.
Check for the product code SZ380R on the removal key. The device was sold with UDI-DI: 04046964719622.
Reach out to Aesculap Implant Systems LLC for specific instructions on how to verify the product and get further assistance.
The recall states the device can fracture or break if the 90-degree angle is not met during use, so it is not safe to use without proper technique.
Look for the product code SZ380R on the removal key and the UDI-DI: 04046964719622.
Contact Aesculap Implant Systems LLC for specific instructions on how to verify the product and get further assistance.
We’ve drafted a message you can send Aescul: Aesculap Implant Systems LLC to request your refund or repair — edit it as you like.
Subject: Recall Z-1428-2022 — Aescul: Aesculap Implant Systems LLC Aescul: Aesculap Implant Systems LLC Hello, I own a Aescul: Aesculap Implant Systems LLC that is covered by recall Z-1428-2022 from Aescul: Aesculap Implant Systems LLC. 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.
