Zimmer Biomet Recalls Sterile Tibial Intramedullary Nails Due to Packaging Failures
Zimmer Biomet is recalling sterile tibial intramedullary nails because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
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 does not report any hospitalizations, injuries, or illnesses. The hazard is limited to packaging design verification test failures, which fits the criteria for a moderate severity score involving low-risk contamination or precautionary measures without reported harm.
Plain-English summary
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged tibial intramedullary nails (IM Nails) and specific knee, hip, and nail implant accessories. The recall involves 9,867 units of the Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories. The specific item number is 00225344015, and the affected lots have expiry dates before March 2027.
The reason for this field action is that the sterile-packaged implants, which are packaged in two different configurations, failed packaging design verification tests. These tests are critical for ensuring the integrity of the sterile barrier system. The agency has classified this recall as Class II.
The affected products were distributed worldwide, including nationwide in the United States and in numerous foreign countries such as Argentina, Australia, Belgium, Brazil, Canada, France, India, Japan, and others. Healthcare providers and facilities that have received these specific implants should stop using them and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 9,867
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 (2)
- Item Number:00225344015
- Lot Number Expiry Date Before: March 2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 35 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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