FDA-Device2025-04-02Class II
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
Zimmer, Inc.
Hazard
The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.
Sold states
Worldwide - US Nationwide distribution in the states pf CA, KS, MA, MD, ME, NE, NJ, OR, SD, and TX. The countries of Canada, China, India, Netherlands, Singapore.
Affected count
76 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1433-2025Don't want to check this manually?
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