NexGen Tibial Plate Recalled for Incorrect Outer Packaging Label
Zimmer, Inc. is recalling NexGen Precoat Stemmed Tibial Plate Size 5 devices due to incorrect outer packaging labeling. Affected units were distributed internationally in India.
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 FDA Class II device recall involves a minor labeling error on the outer packaging with no reported injuries or illnesses. According to the severity rubric, minor labeling errors are classified as Moderate (score 2).
Plain-English summary
Zimmer, Inc. is recalling the NexGen Precoat Stemmed Tibial Plate Size 5. The outer packaging of affected units is incorrectly labeled.
The recall affects devices with Model Number 00598004701 distributed internationally in India, including lot numbers J7418537 and J7418542. The incorrect packaging labeling may impact proper identification and handling of the device.
Consumers and healthcare providers with affected devices should contact Zimmer, Inc. for instructions and guidance. No injuries or illnesses related to the incorrect labeling have been reported.
For additional information and device identification details, consult the FDA recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-2092-2023
The recalled product
- Product
- NexGen Precoat Stemmed Tibial Plate Size 5
- Manufacturer
- Zimmer, Inc.
- Hazard
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 (1)
- Model No. 00598004701
Distribution
Distribution scope not specified by the agency.
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