Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures
Zimmer Biomet is recalling sterile femoral intramedullary nails because packaging design verification tests failed. The action affects 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. The hazard is a packaging design verification failure, which is a quality control issue that may compromise sterility, but the source text does not report any illnesses, injuries, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary actions without reported harm.
Plain-English summary
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged femoral intramedullary nails. The specific product involved is the Fem IM Nail 14mmdx50cm right, sterile rod, fixation, intramedullary, and accessories. The recall covers 9,867 units of these implants.
The reason for the field action is that the sterile-packaged implants, which were packaged in two different configurations, failed packaging design verification tests. The source text does not specify the exact nature of the verification failures or whether any patient harm has occurred.
The affected products were distributed worldwide, including in the United States and numerous foreign countries such as Argentina, Australia, Belgium, Brazil, Canada, and others. The specific item number is 00225750014, and the lot numbers have expiry dates before March 2027. Healthcare providers and facilities should check their inventory for these specific sterile-packaged implants and contact Zimmer Biomet for instructions on how to proceed.
The recalled product
- Product
- Fem IM Nail 14mmdx50cm right, 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:00225750014
- 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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