Zimmer Biomet Recalls Sterile Intramedullary Femoral Stems Due to Packaging Failures
Zimmer Biomet is recalling sterile intramedullary femoral stems and accessories because packaging design verification tests failed. The action covers 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 and involves packaging design verification test failures. The source text does not report any illnesses, injuries, or deaths, and the hazard is related to packaging integrity rather than a direct biological or mechanical defect causing immediate harm.
Plain-English summary
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged implants. The specific products involved are Por fullct fem st 20x200mm, sterile intramedullary fixation rods, and specific knee, hip, and nail implant accessories. The recall was triggered by packaging design verification test failures for implants packaged in two different configurations.
The recall covers 9,867 units with Item Number 00784302008 and an expiry date before July 2026. These devices were 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.
Healthcare providers and facilities should stop using these specific sterile implants and contact Zimmer Biomet for instructions on return or replacement. Patients who have already received these implants should consult their healthcare provider for guidance on the potential impact of the packaging verification failures.
The recalled product
- Product
- Por fullct fem st 20x200mm, 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: 00784302008
- Lot Number Expiry Date Before: July 2026
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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