Z-1433-2025 Class II Ongoing
FDA device recall Z-1433-2025 was initiated by Zimmer, Inc. on February 27, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 76 units.
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