Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile femoral intramedullary nails because packaging design verification tests failed. The recall affects 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. The hazard is a packaging design verification failure, which is a quality control issue rather than a direct, reported injury or high-risk pathogen. No illnesses or injuries are reported in the source text.
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 9,867 units of the Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories. These products are identified by Item Number 00225246016 and have expiry dates before March 2027.
The recall was initiated due to packaging design verification test failures. The sterile implants were packaged in two different package configurations that did not pass these verification tests. The products were distributed nationwide in the United States and to numerous foreign countries, including Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, France, India, Italy, Japan, and others.
Healthcare providers and facilities that have received these products should stop using them and contact Zimmer Biomet for further instructions. Consumers are not expected to have these medical devices in their homes, but should contact their healthcare provider if they have questions regarding implants they have received.
The recalled product
- Product
- Fem IM Nail 16mmdx46cm, 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:00225246016
- 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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