Zimmer Biomet Recalls Sterile Femoral Intramedullary Nail Implants
Zimmer Biomet is recalling sterile femoral intramedullary nail implants 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 cites packaging design verification test failures without reporting any illnesses, injuries, or specific contamination, fitting the criteria for a moderate severity precautionary action.
Plain-English summary
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged femoral intramedullary nail implants. The specific product affected is the Fem IM Nail 14mmdx50cm left, sterile rod, fixation, intramedullary and accessories, with item number 00225750004. The recall covers units with an expiry date before March 2027.
The recall was initiated because the sterile-packaged implants, which were packaged in two different package configurations, failed packaging design verification tests. This field action involves 9,867 units.
The affected products were distributed worldwide, including nationwide in the United States and in various foreign countries such as Argentina, Australia, Belgium, Brazil, Canada, and others. Healthcare providers and facilities that have received these specific implants should stop using them and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Fem IM Nail 14mmdx50cm left, 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:00225750004
- 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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