FDA recall Z-2673-2020

Medtronic Xomed, Inc. · Class II · device

Product

Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.

Reason for recall

During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cosole.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, AK, AZ, AR, CA,CO, CT, FL, GA, HI, ID,IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, PA, RI, SC, TN, TX, UT, VA, WV, WA, WI. The countries of Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Greece, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Sweden, Switzerland, United Kingdom.

Key facts

Status
Terminated
Initiation date
2020-06-12
Report date
2020-07-29
Termination date
2023-04-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Jacksonville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2673-2020