Zimmer Biomet Recalls Tibial Intramedullary Nails Due to Packaging Failures
Zimmer Biomet is recalling sterile tibial intramedullary nails because packaging design verification tests failed. The action affects 1,499 units distributed domestically and internationally.
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, and the hazard is a packaging design verification failure. Since no specific injuries, illnesses, or deaths are reported in the source text, and the defect is related to packaging rather than a direct structural failure of the implant itself, it fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is initiating a field action for specific sterile-packaged tibial intramedullary nails. The recall involves 1,499 units of various sizes, including 15mm x 26cm, 15mm x 28cm, and 15mm x 30cm configurations. The action is being taken because the packaging design verification tests failed.
The affected products were distributed domestically to numerous U.S. states and territories, including Puerto Rico, Alaska, and California. They were also distributed to foreign locations such as Canada, Germany, and Japan. The source text does not specify the exact nature of the packaging failure or the potential clinical consequences of the defect.
Consumers and healthcare providers should check their inventory for the specific item numbers and lot codes listed in the official recall notice. If the product is found, it should be removed from use and returned to Zimmer Biomet or the authorized distributor according to the company's instructions.
The recalled product
- Product
- TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32CM TIBIAL I/M NAIL 14MMDX34CM TIBIAL I/M NAIL 15MMDX34CM TIBIAL I/M NAIL 14MMDX36CM TIBIAL I/M NAIL 15MMDX36CM TIBIAL I/M NAIL 14MMDX38CM
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1,499
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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