Zimmer Biomet Recalls Dual Mobility Vivacit-E Bearing Due to Sizing Error
Zimmer Biomet is recalling 31 Dual Mobility Vivacit-E bearings because the outer package label indicates a different size than the implant inside.
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 situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error regarding size, which is a significant quality control issue but does not involve a high-risk pathogen or structural defect leading to immediate severe injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 31 units of the Dual Mobility Vivacit-E Bearing, Model Number 110031009. The recall is due to a labeling discrepancy where the outer package is labeled as a Size C 38 mm, but the implant inside the package is a Size E 42 mm.
The affected products were distributed to healthcare facilities in the following US states: FL, ID, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, OR, PA, SC, TX, UT, VA, WI, and WV. The specific lot number for the recalled items is 64755636.
Healthcare providers should check their inventory for this specific model and lot number. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to the recall instructions provided by Zimmer Biomet.
The recalled product
- Product
- Dual Mobility Vivacit-E Bearing, Model Number 110031009
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 31
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 (1)
- Lot Number 64755636
Distribution
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