Z-1433-2025 Class II Ongoing

Recalled by Zimmer, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
April 2, 2025
Initiation Date
February 27, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
76 units

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.

Distribution Pattern

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