FDA-Device2020-10-28Class II
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.
Smith & Nephew, Inc.
Hazard
The anterior locking detail does not meet its design specifications.
Sold states
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.
Affected count
47 devices
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0118-2021Don't want to check this manually?
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