Medtronic Xomed, Inc.: Device Recall
Recall #Z-2461-2025 · 07/17/2025
Recall Details
- Recall Number
- Z-2461-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Medtronic Xomed, Inc.
- Status
- Ongoing
- Date Initiated
- 07/17/2025
- Location
- Jacksonville, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 214
Reason for Recall
Due to out of the box wobble of the driver.
Product Description
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.
Distribution Pattern
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, Switzerland, Turkey, United Arab Emirates, and United Kingdom
Other Recalls by Medtronic Xomed, Inc.
- Class II: Risk 03/10/2025
- Class II: Risk 07/05/2024
- Class I: Dangerous 06/24/2024