FDA-Device2015-12-30Class II
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland
Zimmer, Inc.
Hazard
The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
Sold states
US Distribution to the states of : AR, CA, CO, CT, FL, GA, HI, IL, KS, KY, LA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TX, UT, VA, WA, WI, WV and WY.
Affected count
89 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0453-2016Don't want to check this manually?
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