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 action covers specific lots 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 limited to packaging design verification test failures, which is a low-risk contamination or packaging issue without reported injuries, fitting the Moderate severity criteria.
Plain-English summary
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged Fem IM Nail 15mmdx46cm implants. The recall involves specific knee, hip, and nail implants that were packaged in two different configurations. The action was taken due to packaging design verification test failures.
The affected product is identified by Item Number 00225246015. The recall includes lots with an expiry date before March 2027. These sterile implants are used for intramedullary fixation.
The product was 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. The source text does not specify the exact number of units affected or report any illnesses or injuries associated with this field action.
Healthcare providers and patients should verify if they have used or possess the specific item number and lot dates mentioned. If the product is in use, medical professionals should contact Zimmer Biomet for instructions on replacement or removal.
The recalled product
- Product
- Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
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:00225246015
- 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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