FDA Medical devices recall ·
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer… recall
- Recall number
- Z-1433-2025
- Date
- (initiated February 27, 2025)
- Company / brand
- Zimmer, Inc.
1800 W Center St, Warsaw, IN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 76 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00889024666214; Lot Numbers: 66789408, 66792792
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.
States: California Kansas Massachusetts Maryland Maine Nebraska New Jersey Oregon South Dakota Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1433-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.