Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures
Zimmer Biomet is recalling sterile femoral intramedullary nails and accessories because packaging design verification tests failed.
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 a packaging design verification failure. There are no reports of illness, injury, or death, and the hazard is related to potential loss of sterility rather than a direct structural defect or high-risk pathogen.
Plain-English summary
Zimmer Biomet, Inc. has initiated a field action 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 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories.
The action was taken because the sterile packaging failed design verification tests. The affected products were distributed worldwide, including in the United States and numerous foreign countries such as Argentina, Australia, Canada, France, and Japan. The specific item number is 00225242016, and the lot numbers have expiry dates before March 2027.
Healthcare providers and facilities should stop using these specific sterile implants and contact Zimmer Biomet for instructions on return or replacement. Patients who have already received these implants should consult their healthcare provider for guidance.
The recalled product
- Product
- Fem IM Nail 16mmdx42cm, 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: 00225242016
- 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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