FDA recall Z-1608-2024

Product

NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.

Reason for recall

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.

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2024-03-28

Report date

2024-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1608-2024