FDA-Device2024-05-01Class II
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Zimmer, Inc.
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.
Sold states
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.
Affected count
5,546 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1608-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief