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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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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