Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures
Zimmer Biomet is recalling sterile femoral 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 and involves packaging design verification test failures without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged femoral intramedullary nails and specific knee, hip, and nail implant accessories. The recall involves the Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories.
The recall was initiated due to packaging design verification test failures. The affected products were packaged in two different package configurations. A total of 9,867 units are involved in this action.
The affected products were distributed nationwide in the United States and in numerous foreign countries, including Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, France, India, Italy, Japan, and others. The specific item number is 00225250016, and the lot numbers have expiry dates before March 2027. Healthcare providers should contact Zimmer Biomet for instructions on how to handle the affected devices.
The recalled product
- Product
- Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- 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:00225250016
- 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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