Zimmer Biomet Recalls Sterile-Packaged Femoral Intramedullary Nails
Zimmer Biomet is recalling sterile-packaged femoral intramedullary nails due to packaging design verification test failures.
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: The recall is classified as FDA Class II, and the hazard is a packaging design verification failure without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is initiating a field action for sterile-packaged femoral intramedullary nails (FEM IM Nails) packaged in a single package configuration. The recall involves 27,279 units of various sizes and lengths, including 10mm to 16mm diameters and 30cm to 50cm lengths.
The field action is being taken due to packaging design verification test failures. The source text does not specify the nature of the test failures or whether any adverse health consequences have been reported.
The affected products were distributed domestically across all 50 U.S. states, Puerto Rico, and various foreign countries including Canada, Australia, and the United Kingdom. Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL 16MMDX32CM FEM IM NAIL 14MMDX34CM FEM IM NAIL 15MMDX34CM FEM IM NAIL 16MMDX34CM FEM IM NAIL 14MMDX36CM FEM IM NAIL 15MMDX36CM FEM IM NAIL 14MMDX38CM FEM IM NAIL…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 27,279
Distribution
Part of a larger recall action
This product is one of 8 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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