Zimmer Biomet Recalls Sterile-Packaged Femoral Intramedullary Nails
Zimmer Biomet is recalling sterile-packaged femoral intramedullary nails due to packaging design verification test failures.
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 source text explicitly cites packaging design verification test failures without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is initiating a field action for sterile-packaged femoral intramedullary nails (FEM IM Nails). The recall involves 24,969 units of various sizes and configurations, including left and right-sided implants ranging from 10mm to 14mm in diameter and 30cm to 50cm in length.
The reason for the field action is packaging design verification test failures. The source text does not specify the nature of the test failures or any reported injuries, illnesses, or deaths associated with the use of these devices.
The affected products were distributed domestically across all 50 U.S. states and Puerto Rico, as well as to numerous foreign countries including Canada, Australia, China, Germany, and the United Kingdom. Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the return or replacement of these specific sterile-packaged implants.
The recalled product
- Product
- FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM LEFT FEM IM NAIL 13MMDX32CM RIGHT FEM IM NAIL 14MMDX32CM RIGHT FEM IM NAIL 11MMDX34CM LEFT FEM IM NAIL 13MMDX34CM LEFT FEM IM NAIL 14MMDX34CM LEFT FEM IM NAIL 11MM
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 24,969
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)
- 510K: K965098
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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