Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of f…

Recall date: August 8, 2018
Source: U.S. Food & Drug Administration (FDA) — enforcement report
Recall number: Z-0162-2019
FDA classification: Class II
Brand / firm: Zimmer Biomet, Inc.
Sold / distributed: 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, N…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures

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