FDA-Device2018-09-19Class II

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 320 mm, Item Number: 814409320

Zimmer Biomet, Inc.
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¿ 9 mm x 320 mm, Item Number: 814409320

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3081-2018

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