Brainlab Knee Navigation Cutting Block Adapter Base Recalled for Material Error
Brainlab AG is recalling specific femoral and tibial cutting block adapter bases because they may contain incorrect material, making them unsuitable for reprocessing.
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. The hazard involves incorrect material affecting reprocessing suitability, which is a significant quality issue but does not explicitly report hospitalizations or structural defects causing immediate injury, fitting the Moderate criteria for low-risk contamination or precautionary recalls.
Plain-English summary
Brainlab AG is recalling 29 units of the Femoral and Tibial Cutting Block Adapter Base, part of the Brainlab Knee Navigation System. The recall affects specific serial numbers of the adapter base and related kits. The issue is that these units might contain parts made from incorrect material, which renders them unsuitable for reprocessing.
The affected products were distributed to consignees in the United States, specifically in New York, Wisconsin, Oklahoma, and the District of Columbia. Additionally, units were shipped to foreign consignees in Australia, Belarus, Germany, India, Japan, Malaysia, Singapore, Switzerland, the United Arab Emirates, and the United Kingdom.
Healthcare facilities and consumers should stop using the affected serial numbers immediately. Brainlab AG is the recalling firm responsible for managing this safety correction.
The recalled product
- Product
- Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
- Manufacturer
- Brainlab AG
- Affected units
- 29
Distribution
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