Recall of Medtronic Xomed IPC POWEREASE System with out-of-box wobble risk during spinal surgery. Affected units have specific serial numbers and UDI-DI codes.
Due to out of the box wobble of the driver.
Medtronic Xomed is recalling certain IPC POWEREASE surgical systems due to potential wobble when first used. This could affect stability during spinal procedures, though the risk is described as a manufacturing issue rather than a safety hazard.
The system can wobble when first assembled, which might cause instability during spinal surgery. This could potentially lead to inaccurate placement of surgical components, but the risk is described as a manufacturing issue rather than a safety hazard.
Surgical teams using the IPC POWEREASE System for spinal procedures are most at risk. Patients undergoing surgery with these specific units may be affected.
Check for serial numbers starting with PEU21207 through PEU23339 or UDI-DI codes 00613994448705 and 00643169406834. The product is used in spinal surgery procedures.
Look for serial numbers starting with PEU21207 through PEU23339 on the device packaging or label.
The recall is due to out-of-box wobble of the driver, which could affect stability during spinal surgery procedures.
The recall describes a potential wobble issue but does not indicate a risk of serious injury or death. The hazard is described as a manufacturing issue rather than a safety hazard.
Check the serial numbers and UDI-DI codes to see if your device is affected. If it is, contact Medtronic Xomed for further instructions.
We’ve drafted a message you can send Medtronic Xomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2461-2025 — Medtronic Xomed Medtronic Xomed Hello, I own a Medtronic Xomed that is covered by recall Z-2461-2025 from Medtronic Xomed. 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.
