FDA-Device2018-03-14Class II

Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040

Zimmer Biomet, Inc.
Hazard

The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in infection and subsequent complications.

Sold states
Distributed in 31 states: AL, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI and the District of Columbia.
Affected count
127
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0919-2018

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