# FDA recall Z-2461-2025

> **Medtronic Xomed, Inc.** · Class II · device recall initiated 2025-07-17.

## Product

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.

## Reason for recall

Due to out of the box wobble of the driver.

## 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

## Key facts

- **Recall number:** Z-2461-2025
- **Recalling firm:** Medtronic Xomed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-17
- **Report date:** 2025-09-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jacksonville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2461-2025

## Citation

> AI Analytics. FDA recall Z-2461-2025. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2461-2025. Source: US FDA. Licensed CC0.

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