NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented p...
FDA Recall #Z-1433-2025 — Class II — February 27, 2025
Product Description
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
Reason for Recall
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.
Recalling Firm
Zimmer, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
76 units
Distribution
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.
Code Information
UDI-DI: 00889024666214; Lot Numbers: 66789408, 66792792
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated