Mako Surgical Recalls MAKOplasty Hip Array Kit Laminate Due to Labeling Error
Mako Surgical Corporation is recalling 10 units of the MAKOplasty Hip Array Kit Laminate 150230 because the product may list two part numbers for the RIO Base Array.
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, but the source text describes a labeling error (listing two part numbers) without any reported injuries or illnesses, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Mako Surgical Corporation is recalling 10 units of the MAKOplasty Hip Array Kit Laminate 150230 (Catalog No. 210540, Lot Code: 150324). The recall was initiated after Stryker Orthopaedics became aware that the product may list two part numbers for the RIO Base Array, which is item #5 on the product table.
The affected units were distributed in Colorado, Kentucky, Minnesota, Washington, and West Virginia. The source text does not specify any reported injuries, illnesses, or adverse health consequences associated with this labeling discrepancy.
Consumers and healthcare providers who have this specific product should contact Mako Surgical Corporation for further instructions on how to proceed with the recall.
The recalled product
- Product
- MAKOplasty Hip Array Kit Laminate 150230
- Manufacturer
- Mako Surgical Corporation
- Hazard
- Affected units
- 10
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 (2)
- Catalog No. 210540
- Lot Code: 150324
Distribution
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