Lower risk Medical device recall · FDA · Published July 17, 2025

Medtronic Xomed IPC POWEREASE System Recall: Out-of-Box Wobble Hazard

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2461-2025Medical device Medtronic Xomed ›

Lower-risk recall

Due to out of the box wobble of the driver.

Take action

Contact the company

Recalling firmMedtronic Xomed, Inc.6743 Southpoint Dr N · Jacksonville, FL 32216-6218

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/51778-medtronic-xomed-ipc-powerease-system-recall-out-of-box-wobble.

Source Summary by GovInfoNow · govinfonow.com/recall/51778-medtronic-xomed-ipc-powerease-system-recall-out-of-box-wobble · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2461-2025

Cite this page

“Medtronic Xomed IPC POWEREASE System Recall: Out-of-Box Wobble Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51778-medtronic-xomed-ipc-powerease-system-recall-out-of-box-wobble. Based on FDA recall #Z-2461-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2461-2025%22&limit=1).

The FDA announced on July 17, 2025, that Medtronic Xomed, Inc. is recalling the IPC Powerease System due to out-of-the-box wobble of the driver. The recall affects 214 units distributed in the U.S. and internationally.

How to tell if you have it

Brand: Medtronic Xomed
Product: IPC Powerease System
REF: 2300000
UDI-DI: 00613994448705
Lot codes under UDI-DI 00613994448705: PEU21207 through PEU21305, PEU23001 through PEU23010, PEU23013, PEU23015-PEU23016, PEU23024, PEU23027, PEU23031, PEU23044, PEU23049-PEU23080, PEU23083, PEU23086-PEU23089, PEU23098-PEU23099, PEU23100-PEU23101, PEU23105-PEU23112, PEU23125-PEU23127, PEU23133-PEU23136, PEU23140, PEU23142-PEU23143, PEU23146, PEU23149, PEU23159-PEU23161, PEU23163-PEU23167, PEU23170-PEU23183, PEU23196-PEU23199, PEU23207-PEU23208, PEU23210, PEU23215-PEU23216, PEU23218-PEU23225, PEU23229-PEU23231, PEU23235, PEU23249, PEU23251, PEU23253, PEU23268, PEU23277-PEU23278, PEU23281-PEU23283, PEU23288-PEU23289, PEU23291-PEU23293, PEU23303-PEU23306, PEU23310-PEU23314, PEU23316-PEU23319, PEU23322-PEU23327, PEU23338-PEU23339
UDI-DI: 00643169406834
Lot codes under UDI-DI 00643169406834: PEU23011, PEU23012, PEU23066-PEU23067, PEU23069, PEU23137-PEU23139, PEU23147, PEU23173-PEU23174, PEU23274, PEU23276, PEU23279-PEU23280

The hazard

The IPC Powerease System is indicated for drilling, tapping, and driving screws during spinal surgery and other procedures. The recall cites the hazard of out-of-the-box wobble of the driver.

Context

GovInfoNow's records show Medtronic Xomed, Inc. has 11 other recalls on record since November 13, 2019. Recent brand recalls include a March 10, 2025 recall of the NIM Vital Nerve Monitoring System for potential procedure delays and a July 5, 2024 recall of Ultra Round Steel Cutting Burs due to expired product distribution. Other recent recalls of similar products include Philips Azurion 5 M12 System Software Recalls (January 26, 2026), Philips Azurion 3 M15 System Recall (January 26, 2026), and Philips Azurion 7 B20 System Recall (January 26, 2026).

How to tell if you have this one

Check for serial numbers starting with PEU21207 through PEU23339 or UDI-DI codes 00613994448705 and 00643169406834. The product is used in spinal surgery procedures.

Brand
Medtronic Xomed
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Look for serial numbers starting with PEU21207 through PEU23339 on the device packaging or label.

Where it went and when

Where it was distributed

Distributed in 25 states, and outside the U.S.

FDA distribution: “U.S.: AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, SC, TN, TX, O.U.S.: Canada, China, Croatia, France, Germany, India, Italy, Japan, Jordan, Kuwait, Norway, Romania, South Korea, Spain, Sweden,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oregon, South Carolina, Tennessee, Texas.

Recall timeline

FDA published this recall 48 days after the firm started it.

Jul 17, 2025Firm started the recall
Aug 27, 2025FDA classified it Class II
Sep 3, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/51778-medtronic-xomed-ipc-powerease-system-recall-out-of-box-wobble">Medtronic Xomed IPC POWEREASE System Recall: Out-of-Box Wobble Hazard (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-2461-2025 (July 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2461-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.