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Zimmer, Inc. recalls NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Recalled May 1, 2024 · FDA recall Z-1608-2024 · Zimmer
Hazard
Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate. · FDA Class II
Units
5,546 units
Sold at
Worldwide distribution - US Nationwide including the states of AK, AL, CA, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and the countries of Australia, Canada, Japan, Netherlands.
Description
Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
Product
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Manufacturer(s)
Zimmer, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →