Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures
Zimmer Biomet is recalling sterile femoral intramedullary nails and accessories due to packaging design verification test failures.
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, but the source text identifies the cause as packaging design verification test failures without reporting any illnesses, injuries, or specific contamination events, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged implants. The affected products are the Fem IM Nail 16mmdx40cm, sterile rod fixation intramedullary implants, and specific knee, hip, and nail implant accessories. The recall was triggered by packaging design verification test failures for implants packaged in two different package configurations.
The recall involves 9,867 units of the product. The specific item number is 00225240016, and the affected lots have expiry dates before March 2027. The products were distributed worldwide, including nationwide in the United States and in numerous foreign countries such as Argentina, Australia, Belgium, Brazil, Canada, and France.
Consumers and healthcare providers should stop using these specific sterile-packaged implants and contact Zimmer Biomet, Inc. for further instructions regarding the field action.
The recalled product
- Product
- Fem IM Nail 16mmdx40cm, 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: 00225240016
- 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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