Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC Recalled by Medtronic Xomed, Inc. Due to Due to out of the box wobble of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Xomed, Inc. directly.
Affected Products
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws, or cutting of screws, posts, and rods. The IPC is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
Quantity: 214
Why Was This Recalled?
Due to out of the box wobble of the driver.
Where Was This Sold?
This product was distributed to 25 states: AZ, CA, CO, CT, FL, GA, IL, IN, IA, LA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, OR, SC, TN, TX
About Medtronic Xomed, Inc.
Medtronic Xomed, Inc. has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report