FDA-Device2018-11-21Class II
Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
Zimmer Biomet, Inc.
Hazard
The set screw is not able to advance or reverse from the original position in the nail.
Sold states
Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and foreign countries of: Chile, Costa Rica, Ecuador and Netherlands.
Affected count
2,163 in total (expanded)
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0451-2019Don't want to check this manually?
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