MAKOplasty Hip Array Kit Laminate 150230
FDA Device Recall #Z-1588-2016 — Class II — November 25, 2015
Recall Summary
| Recall Number | Z-1588-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 25, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Mako Surgical Corporation |
| Location | Plantation, FL |
| Product Type | Devices |
| Quantity | 10 units. |
Product Description
MAKOplasty Hip Array Kit Laminate 150230
Reason for Recall
Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.
Distribution Pattern
CO, KY, MN, WA and WV
Lot / Code Information
Catalog No. 210540, Lot Code: 150324
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-1823-2019 | Class II | 2.7 Degree Angled Sagittal Saw attachment (Mako... | Apr 25, 2019 |
| Z-1824-2019 | Class II | 2.7 Degree Straight Sagittal Saw attachment (Ma... | 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.