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 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, but the source text attributes the action to packaging design verification test failures rather than a confirmed defect in the implant itself or reported injuries. This aligns with the rubric for moderate severity involving packaging issues or voluntary precautionary measures without reported harm.
Plain-English summary
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged intramedullary nail implants. The recall involves the Fem IM Nail 14mmdx48cm right, sterile rod fixation implants and specific knee, hip, and nail accessories. The action was taken because the packaging design failed verification tests.
The recall covers 9,867 units of the product, identified by Item Number 00225748014, 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, France, India, Japan, and others.
Healthcare providers and facilities that have received these implants should stop using them and contact Zimmer Biomet for instructions on how to return or dispose of the product. Patients who have already had these implants placed should contact their healthcare provider for guidance.
The recalled product
- Product
- Fem IM Nail 14mmdx48cm 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:00225748014
- 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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