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U.S. Department of Health and Human Services

Class 2 Device Recall Robotic Arm Interactive Orthopedic System (RIO)

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  Class 2 Device Recall Robotic Arm Interactive Orthopedic System (RIO) see related information
Date Initiated by Firm January 22, 2015
Date Posted February 19, 2015
Recall Status1 Terminated 3 on December 14, 2016
Recall Number Z-1128-2015
Recall Event ID 70374
510(K)Number K112507  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product 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.
Code Information All lots, Part Numbers: 201000, 203999, 207300, and 209930.
Recalling Firm/
Manufacturer		 Mako Surgical Corporation
2555 Davie Rd Ste 110
Plantation FL 33317-7424
For Additional Information Contact Clayton Odor
954-629-0502
Manufacturer 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
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = MAKO SURGICAL CORPORATION
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