Medtronic IPC Powerease Surgical System Recalled for Driver Wobble
Medtronic is recalling 214 IPC Powerease surgical systems due to out-of-box wobble of the driver component. Units were distributed across 25 U.S. states and multiple countries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device with a mechanical defect in a surgical power tool. No injuries or illnesses are reported in the source material, but the wobbling driver creates a risk of compromised surgical precision and potential patient harm during surgical procedures.
Plain-English summary
The IPC Powerease System, manufactured by Medtronic Xomed Inc., is a surgical power tool indicated for drilling, tapping, and driving screws during spinal, orthopedic, neurosurgical, and other surgical procedures. Medtronic has issued a recall for 214 units (product number 230000) due to out-of-box wobble of the driver component.
The wobbling driver affects the stability of the surgical instrument during use. This mechanical defect may impact the tool's precision and performance during critical surgical procedures.
Affected units bear UDI-DI codes 00613994448705 and 00643169406834, with specific lot numbers listed from PEU21207 through PEU23339. These units were distributed in 25 U.S. states: Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, South Carolina, Tennessee, and Texas, as well as Canada, China, Croatia, France, Germany, India, Italy, Japan, Jordan, Kuwait, Norway, Romania, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
Healthcare facilities with affected units should stop use immediately and contact Medtronic for replacement or return instructions.
The recalled product
- 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 S
- Manufacturer
- Medtronic Xomed, Inc.
- Hazard
- mechanical-defect
- equipment-wobble
Distribution
Distributed in 25 states:
- 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
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