FDA-Device2018-10-24Class II
Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 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
60
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Product Usage: Intended for the fixation of fractures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0152-2019Don't want to check this manually?
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