FDA Devices recall · Reported February 25, 2015
Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and tr…
Mako Surgical Corporation recalled Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm In… - a moderate-severity action.
Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm In… was recalled by Mako Surgical Corporation in February 25, 2015. Reason: When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the s…. Check the official notice for the remedy. Verify recall #Z-1128-2015 with the FDA Devices before acting.
The recall
Mako Surgical Corporation issued this moderate-severity FDA Devices recall-When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the s….
- Moderate
- severity level
- 228 units
- affected scope
- Class II
- classification
- February 25, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1128-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1128-2015) was formally reported on February 25, 2015, with the manufacturer initiating the action on January 22, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Mako Surgical Corporation is listed as the recalling firm, operating out of Plantation, FL. Federal records list the affected scope as 228 units.
The documented reason for this recall is: When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated Distribution data in the federal record shows the product reached: Nationwide Distribution-including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
Reason for recall
When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1128-2015 |
| Date reported | February 25, 2015 |
| Date initiated | January 22, 2015 |
| Recalling firm | Mako Surgical Corporation |
| Firm location | Plantation, FL |
| Affected scope | 228 units |
| Distribution | Nationwide Distribution-including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1128-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Methodology · Corrections · Archive as of August 2026