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 due to packaging design verification test failures. No illnesses, injuries, or deaths are reported in the source text, and the hazard is related to packaging integrity rather than a direct product defect causing harm.
Plain-English summary
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged femoral intramedullary nails (Fem IM Nail 16mmdx44cm) and specific knee, hip, and nail implant accessories. The recall was triggered by packaging design verification test failures for implants packaged in two different configurations.
The affected product is identified by Item Number 00225244016 and includes units with expiry dates before March 2027. A total of 9,867 units were distributed nationwide in the United States and to numerous foreign countries, including Argentina, Australia, Belgium, Brazil, Canada, France, India, Japan, and others.
This is a Class II recall, indicating that use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences. Healthcare providers and facilities should stop using the affected sterile implants and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Fem IM Nail 16mmdx44cm, 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: 00225244016
- 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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