Z-1128-2015 Class II Terminated
FDA device recall Z-1128-2015 was initiated by Mako Surgical Corporation on Jan 22, 2015 and is designated Class II. 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… The recall status is terminated (terminated Dec 14, 2016). Affected quantity: 228 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 25, 2015
- Initiation Date
- Jan 22, 2015
- Termination Date
- Dec 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 228 units
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
Distribution Pattern
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.
Code Information
All lots, Part Numbers: 201000, 203999, 207300, and 209930.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1128-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026