Aesculap recalls ENNOVATE MIS REMOVALKEY SHORT (product code SZ380R) after risk of spinal fixation arm fracture during spinal surgery procedures.
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. Redesign of removal key.
Aesculap is recalling a short spinal removal key that could fracture or break if used incorrectly during spinal surgery. This poses a risk of serious injury to patients during spinal procedures.
The spinal fixation arm can fracture or break if the removal key is not used at a 90-degree angle with the spinal fixation system. This could cause serious injury during spinal surgery procedures.
Surgical teams using the ENNOVATE MIS REMOVALKEY SHORT (product code SZ380R) for spinal procedures are most at risk. Patients undergoing spinal surgery with this device may be affected.
Check for the product code SZ380R on the removal key. The device was sold with a UDI-DI number 04046964719622.
Look for the product code SZ380R on the removal key or UDI-DI number 04046964719622.
Yes, the device can fracture or break if not used at a 90-degree angle with the spinal fixation system, potentially causing serious injury during spinal surgery.
Check for the product code SZ380R or UDI-DI number 04046964719622. Contact Aesculap for guidance.
The recall includes a redesign of the removal key, but no specific fix steps are mentioned in the official notice.
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-1429-2022 — 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-1429-2022 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.
