Device product
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
Z-1433-2025
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
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.