Zimmer Biomet Recalls Ultra-Drive Hose/Drape Assembly Due to Shelf Life Data
Zimmer Biomet is recalling 8,478 Ultra-Drive Hose/Drape Assemblies because there is insufficient 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, and the source text cites insufficient data for shelf life without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 8,478 units of the Ultra-Drive Hose/Drape Assembly, Reference Number 423833. This product 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 lots include 221437, 211324, 211638, 212670, 212877, 213350, 213612, 214315, 214545, 214994, 216550, 216610, 217760, 217766, 218921, and 219825.
The products were distributed worldwide, including in the United States, Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, the Netherlands, and Taiwan. Healthcare providers and facilities should stop using the affected products and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · shelf life data deficiency
See all →- ModerateAdvanced Sterilization Products Recalls STERRAD CYCLESURE 24 Biological Indicators
FDA (Devices) · 2013-05-08