FDA-Device2016-12-28Class II
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Exactech, Inc.
Hazard
Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
Sold states
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MD, ME, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TN, VA, WA and WI., and to the countries of : Austria, Australia, Canada, Germany, France, Spain, India, Switzerland, Italy, South Korea, United Kingdom, Brazil, Luxembourg, Greece, Guatemala, Netherlands, South Africa, and Sweden
Affected count
2,278 units
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0900-2017Don't want to check this manually?
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