Zimmer Biomet Recalls Sterile Porous Femoral Stems Due to Packaging Failures
Zimmer Biomet is recalling sterile porous femoral stems because packaging design verification tests failed. The action affects 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 potential risk to sterility but does not involve reported injuries or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged porous femoral stems. The recall involves item number 00784301708 with an expiry date before July 2026. The total quantity involved is 9,867 units.
The reason for the recall is packaging design verification test failures. The affected implants were packaged in two different package configurations. The source text does not specify the exact nature of the packaging defect or whether the sterility of the implants was compromised.
The affected products 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. Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Por fullct fem st 17x200mm, Sterile,
- 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: 00784301708
- 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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