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.
FDA Recall Z-1128-2015 · Posted 2015-02-19
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Recalling FirmMako Surgical Corporation
Recall StatusTerminated
Product CodeOLO
Date Initiated2015-01-22
Date Terminated2016-12-14
Product Quantity228 units
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
Firm Action
On January 22, 2015 the firm sent an IMPORTANT MEDICAL DEVICE CORRECTION asking consignees to complete the attached acknowledgement form and return them by email, fax or mail. The notice also noted the RIO system can continue to be used. The likelihood of occurrence is rare (.035% of cases) and the event is readily detectable and can be resolved. Should you have any questions regarding this Important Medical Device Recall Notice, to contact us at (954) 628-1721.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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