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Smith & Nephew, Inc. recalls Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciat
Recalled October 28, 2020 · FDA recall Z-0118-2021 · Smith & Nephew
Hazard
The anterior locking detail does not meet its design specifications. · FDA Class II
Units
47 devices
Sold at
Worldwide distribution - US Nationwide distribution including in the states of CA, NH, NY, GA, MI, TX, IL, OK, LA, OR, FL, AZ, NJ, MO and the countries of AE. BE, BR, CO, DE, ES, FR, GB, HU, IT, PL, PT, TR.
Description
The anterior locking detail does not meet its design specifications.
Product
Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →