Recall Z-2461-2025 · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

Medtronic Xomed, Inc.

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/cut

Date	Aug 27, 2025 (initiated Jul 17, 2025)
Status	Open, Classified
Reason	Due to out of the box wobble of the driver.
Root cause	Process change control
Action	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 coordin
Quantity	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, Romania, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom
FDA record	Open on fda.gov

510(k) clearances named in this recall

K111520

IPC POWEREASE SYSTEM
Medtronic Xomed, Inc., Oct 26, 2011