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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medtronic IPC Powerease System Recalled for Driver Wobble

Agency Publication Date: August 27, 2025
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Summary

Medtronic Xomed, Inc. is recalling 214 units of the IPC Powerease System (REF 2300000), a surgical motor system used during spinal procedures for drilling and driving screws. The recall was issued because the driver component may wobble when used right out of the box. Medtronic has notified affected facilities by letter to arrange for the return or correction of these surgical instruments.

Risk

A wobbling driver during spinal surgery can cause the tool to be unstable, potentially leading to surgical inaccuracies or unintended damage to a patient's soft tissue or bone. While no specific injuries are mentioned, this mechanical defect poses a risk during delicate neurosurgical and orthopedic procedures.

What You Should Do

  1. This recall affects the IPC Powerease System (REF 2300000) used in spinal, orthopedic, and neurosurgical procedures.
  2. Check your surgical inventory for systems with serial numbers beginning with 'PEU'. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately to avoid potential surgical inaccuracies or patient injury.
  4. Contact Medtronic Xomed, Inc. or your local distributor to arrange for the return, replacement, or correction of the affected equipment.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding medical device safety.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: IPC Powerease System
Model / REF:
2300000
230000
Serial Numbers (214):
PEU21207
PEU21208
PEU21210
PEU21211
PEU21212
PEU21213
PEU21214
PEU21215
PEU21216
PEU21217
PEU21218
PEU21219
PEU21221
PEU21222
PEU21224
PEU21225
PEU21226
PEU21227
PEU21228
PEU21229
PEU21230
PEU21231
PEU21239
PEU21240
PEU21246
PEU21247
PEU21248
PEU21251
PEU21252
PEU21253
PEU21254
PEU21255
PEU21257
PEU21259
PEU21263
PEU21264
PEU21265
PEU21266
PEU21267
PEU21268
PEU21269
PEU21270
PEU21273
PEU21274
PEU21277
PEU21278
PEU21279
PEU21285
PEU21286
PEU21294
UDI:
00613994448705
00643169406834

Indicated for drilling, tapping, and driving screws during spinal surgery.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97266
Status: Active
Manufacturer: Medtronic Xomed, Inc.
Sold By: Medical device distributors; Surgical centers; Hospitals
Manufactured In: United States
Units Affected: 214
Distributed To: Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, South Carolina, Tennessee, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.