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Recall Observatory FDA recall evidence

Device product

NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10

Z-1433-2025

February 27, 2025

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 96400
Status
Ongoing
Classification
Class II
Quantity
76 units
Official record key
device-enforcement:Z-1433-2025

Official wording

Reason: 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.

Code information: UDI-DI: 00889024666214; Lot Numbers: 66789408, 66792792

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.