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.
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, 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.
Related recalls
Same manufacturer · Mako Surgical Corporation
See all →- ModerateStryker USB Converter in Mako Robotic Surgery System May Fail
FDA (Devices) · 2022-09-21
- HighMako MICS Handpiece Recalled for Potential Bone Preparation Discrepancies
FDA (Devices) · 2020-11-25
- HighMako Hip End Effector Recalled for Potential Bone Preparation Discrepancy
FDA (Devices) · 2020-08-12
- ModerateMako Surgical Recalls 2.7 Degree Straight Sagittal Saw Attachments
FDA (Devices) · 2019-06-26
- ModerateMako Surgical Recalls 2.7 Degree Angled Sagittal Saw Attachments
FDA (Devices) · 2019-06-26
Same hazard · missing documentation
See all →- ModerateCollagen vascular grafts recalled over incorrect labels missing CE and UKCA marks
FDA (Devices) · 2025-10-15
- HighGE Healthcare Proteus XR/a X-Ray System Missing De-Installation Manual
FDA (Devices) · 2024-09-04
- SevereVentilator Operator's Guide Recalled for Missing Critical MRI Safety Information
FDA (Devices) · 2024-06-26
- HighPregnancy test strips recalled due to manufacturing documentation gaps
FDA (Devices) · 2023-11-01
- HighFDA Recalls Ovulation Test Strips for Unverified Manufacturing and Documentation
FDA (Devices) · 2023-11-01
Similar recalls
- ModerateMako Surgical Recalls Robotic Arm Interactive Orthopedic System Software
FDA (Devices) · 2017-09-20
- SevereMako Surgical Recalls Restoris Partial Knee Application RIO Due to Burr Malfunction
FDA (Devices) · 2015-02-25
- HighMako Surgical Recalls Robotic Knee System Due to Software Display Error
FDA (Devices) · 2017-09-20
- HighMako Surgical Recalls Rio System Irrigation Clips Due to Tolerance Issues
FDA (Devices) · 2018-08-22
- ModerateMako Surgical Recalls RIO Standard System Components for Connection Errors
FDA (Devices) · 2018-09-26
- ModerateMako Surgical Recalls Robotic Arm Interactive Orthopedic System for Manual Revision
FDA (Devices) · 2016-04-27