Mako Surgical Recalls MAKO RIO THA Application User Guides
Mako Surgical Corporation is recalling 777 MAKO RIO THA Application User Guides because five AFMEA Risk Control Measures are missing from the documents.
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 corresponds to a Moderate severity score (2) when no specific hospitalizations or serious injuries are reported, and the hazard is a documentation deficiency rather than a direct physical defect.
Plain-English summary
Mako Surgical Corporation is recalling 777 units of MAKO RIO THA Application User Guides used for total hip arthroplasty in orthopedic surgery. The recall was initiated because five AFMEA Risk Control Measures are missing from the user guides.
The affected products were distributed nationwide in the United States. The specific part item numbers involved in this recall include 204863, 207116, 208692, 209711, 210555, and 212026, covering various versions of the THA Application User Guide.
The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Users should contact Mako Surgical Corporation for further instructions regarding the replacement or correction of these user guides.
The recalled product
- Product
- MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
- Manufacturer
- Mako Surgical Corporation
- Hazard
- Affected units
- 777
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)
- THA 3.1
Distribution
Distributed nationwide across the United States.
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