NexGen LPS Flex knee prosthesis recalled for labeling inconsistency
Zimmer recalls 76 NexGen LPS Flex knee prosthesis units due to conflicting plate compatibility information on the product label.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving a labeling error creating confusion about compatible components. The source reports no illnesses or injuries. The hazard is theoretical—potential for incorrect device use due to conflicting instructions—with no demonstrated harm, consistent with a precautionary recall for minor labeling errors.
Plain-English summary
Zimmer, Inc. is recalling 76 units of the NexGen LPS Flex knee joint prosthesis (Model Number 00-5962-042-10) due to a labeling discrepancy. The top of the product label states "Use with plate 7, 8, 9, 10," while the translations section of the same label states "USE WITH PLATE 5, 6."
The affected devices have been distributed worldwide, including to the United States in the states of California, Kansas, Massachusetts, Maryland, Maine, Nebraska, New Jersey, Oregon, South Dakota, and Texas, as well as Canada, China, India, Netherlands, and Singapore. The involved lot numbers are 66789408 and 66792792.
The recalled product
- Product
- NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
- Manufacturer
- Zimmer, Inc.
- Category
- Medical Device — Knee Prosthesis
- Hazard
- Affected units
- 76
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 00889024666214
- Lot Numbers: 66789408
- 66792792
Distribution
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