Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usa...
FDA Device Recall #Z-3182-2018 - Class II, December 27, 2017
Recall Summary
| Recall Number | Z-3182-2018 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 27, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Mako Surgical Corporation |
| Location | Davie, FL |
| Product Type | Devices |
| Quantity | 736 (US) and 174 (OUS) |
Product Description
Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include Unicondylar knee replacement and/or patellofemoral knee replacement.
Reason for Recall
Communication-connection error.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Australia, New Zealand, Taiwan, China, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Germany, Ireland, Switzerland, Italy, India, Japan, South Korea, Vietnam, South Africa, and Turkey,
Lot / Code Information
ALL LOTS
Other Recalls from Mako Surgical Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1735-2022 | Class II | Stryker USB Converter, Polaris Spectra Camera, ... | Aug 8, 2022 |
| Z-0472-2021 | Class II | Mako Integrated Cutting System (MICS) Handpiece... | Oct 23, 2020 |
| Z-2745-2020 | Class II | Mako Hip End Effector, Variable Angle Catalog ... | Jul 9, 2020 |
| Z-1824-2019 | Class II | 2.7 Degree Straight Sagittal Saw attachment (Ma... | Apr 25, 2019 |
| Z-1823-2019 | Class II | 2.7 Degree Angled Sagittal Saw attachment (Mako... | Apr 25, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.