FDA-Device2018-10-24Class II

Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
Hazard

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Sold states
Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were distributed to the following foreign countries: Chile, Netherlands.
Affected count
10
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 Product Usage: Intended for the fixation of fractures

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0168-2019

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