Zimmer Biomet Recalls Two ROSA BRAIN 3.0.0 Devices for Labeling Errors
Zimmer Biomet is recalling two ROSA BRAIN 3.0.0 devices in Ohio and Pennsylvania due to non-conforming product labels.
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 identifies the issue as a non-conforming product label, which aligns with the rubric for minor labeling errors.
Plain-English summary
Zimmer Biomet, Inc. is recalling two units of the ROSA BRAIN 3.0.0 medical device. The recall was initiated because the products have non-conforming labels.
The affected devices are identified by serial numbers BR16017 and BR16018. These units were distributed to facilities in Ohio and Pennsylvania.
Consumers and healthcare providers who possess these specific serial numbers should contact Zimmer Biomet for further instructions regarding the recall.
The recalled product
- Product
- ROSA BRAIN 3.0.0
- Manufacturer
- Zimmer Biomet, Inc.
- Category
- Medical Device — Neurological
- Hazard
- Affected units
- 2
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)
- Serial No. BR16017 and BR16018
Distribution
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