Zimmer Biomet Recalls Sterile Intramedullary Nail Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile intramedullary nail implants because packaging design verification tests failed. The recall covers 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. There are no reported illnesses, injuries, or deaths, and the hazard is related to packaging integrity rather than a direct product defect causing harm.
Plain-English summary
Zimmer Biomet, Inc. has initiated a field action for sterile-packaged intramedullary nail implants and accessories. The recall involves the Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories, specifically for knee, hip, and nail implants. The action was taken because the packaging design failed verification tests.
The recall covers 9,867 units of the product, identified by Item Number 00225238016, with lot numbers expiring before March 2027. These sterile implants 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.
Consumers and healthcare providers should check their inventory for the specific item number and lot expiration dates listed above. If the product is found, it should be removed from use and returned to the manufacturer or an authorized representative in accordance with the field action instructions.
The recalled product
- Product
- Fem IM Nail 16mmdx38cm, 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: 00225238016
- 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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