FDA-Device2019-05-29Class II
Drill, 2.5x135mm, AO, Item Number 502015142
Zimmer GmbH
Hazard
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Sold states
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
Affected count
N/A
Manufactured in
Sulzerallee 8, N/A, Winterthur, N/A, Switzerland
Products
Drill, 2.5x135mm, AO, Item Number 502015142
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1423-2019Don't want to check this manually?
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