Zimmer Biomet Recalls Ultra-Drive Irrigation Tubing Assembly Due to Shelf Life Data
Zimmer Biomet is recalling 8,478 Ultra-Drive Irrigation Tubing Assemblies because the company lacks sufficient data to support the labeled 10-year shelf life.
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, which typically indicates a temporary or medically reversible adverse health consequence. The specific issue is a lack of data supporting the labeled shelf life, which is a documentation and quality control issue rather than a reported injury or structural defect.
Plain-English summary
Zimmer Biomet, Inc. is recalling 8,478 units of the Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834. This medical device is used with the UltraDrive System to provide irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
The recall was initiated because the products do not have sufficient data to support the labeled shelf life of 10 years. The affected units were distributed worldwide, including the United States, Australia, Brazil, Canada, Chile, China, Colombia, Hong Kong, India, Japan, Malaysia, the Netherlands, and Taiwan.
Healthcare facilities and consumers should stop using the affected tubing assemblies and contact Zimmer Biomet for further instructions. The recall covers specific lot numbers listed in the agency's official documentation.
The recalled product
- Product
- Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 8,478
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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