FDA-Device2018-10-24Class II
Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures
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
19
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0164-2019Don't want to check this manually?
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