# FDA recall Z-2794-2018 > **Mako Surgical Corporation** · Class II · device recall initiated 2018-05-10. ## Product Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) 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 Out of tolerance. ## Distribution Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, Hong Kong, India, Italy, Korea, Midrand Allandale, Netherlands, Singapore, and United Kingdom ## Key facts - **Recall number:** Z-2794-2018 - **Recalling firm:** Mako Surgical Corporation - **Classification:** Class II - **Product type:** device - **Status:** Terminated - **Initiation date:** 2018-05-10 - **Report date:** 2018-08-22 - **Termination date:** 2021-01-17 - **Voluntary/Mandated:** Voluntary: Firm initiated - **Location:** Davie, FL, United States ## Primary source FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2794-2018 ## Citation > AI Analytics. FDA recall Z-2794-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2794-2018. Source: US FDA. Licensed CC0. --- *[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*