FDA-Device2018-09-19Class II

Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 420 mm, Item Number: 814411420

Hazard

The set screw is not able to advance or reverse from the original position in the nail.

Sold states
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.
Affected count
5947 total
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 420 mm, Item Number: 814411420

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3095-2018

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