IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilli
FDA device recall Z-2461-2025 · posted 2025-08-27 · Open, Classified
Recall details
- Recalling firm
- Medtronic Xomed, Inc.
- Reason for recall
- Due to out of the box wobble of the driver.
- Action taken
- On 07/17/2025, the firm initiated distribution of "URGENT: MEDICAL DEVICE RECALL" Letters via email and/or mail to customers informing them of reported out-of-box failures due to device wobble which is due to misalignment between the quick connect and shaft main driver components of the IPC Powerease System Model 2300000. Customers are instructed to: . Identify, segregate, quarantine and stop use of any affected products within your inventory. The list of affected device serial numbers is included in Attachment A: Product Serial Number List. . Your Medtronic field representative will coordinate the replacement of your affected product. . Return affected product in your inventory to Medtronic. Please see Customer Confirmation Form for instructions on returning impacted devices. . Please complete and return the customer confirmation form enclosed with this letter acknowledging receipt of this information via email to neuro.quality@medtronic.com even if you no longer have possession, custody, or control over the affected product. Note: Instructions on returning the acknowledgement form to Medtronic is located on the form itself. . Please share this communication within your organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action. Maintain a copy of this letter for your records. For questions or assistance please contact Medtronic Sales Representative and/or Technical Services at 1-888-826-5603.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- HBE
- Quantity affected
- 214
- 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,
- Date initiated
- 2025-07-17
- Date posted
- 2025-08-27
- Location
- Jacksonville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IPC POWEREASE SYSTEM (K111520) | Medtronic Xomed, Inc. | 2011-10-26 |