Zimmer Biomet Recalls Femoral Distal Assembly Due to Internal Labeling Error
Zimmer Biomet is recalling specific femoral distal assemblies because the internal patient label may be incorrect, although the outer box and product are correctly identified.
What this means for you
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: The recall is classified as FDA Class II, but the hazard is a labeling error with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling the RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817, lot number 856460. The recall is due to a possibility that the patient label inside the product box was incorrectly labeled. The outer box label and the actual product are correctly identified, but the internal patient label could be incorrect.
The affected products were distributed nationwide in the United States and internationally in Argentina, the Netherlands, and Canada. The source text does not specify the number of units affected or report any illnesses or injuries associated with this labeling error.
Consumers and healthcare providers should verify the product identification against the outer box label. If the internal patient label is found to be incorrect, the product should be returned to Zimmer Biomet, Inc. for further instructions.
The recalled product
- Product
- RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817
- Manufacturer
- Zimmer Biomet, 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)
- Lot Number: 856460
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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