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U.S. Department of Health and Human Services

Class 2 Device Recall Rio System Irrigation Clip

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  Class 2 Device Recall Rio System Irrigation Clip see related information
Date Initiated by Firm May 10, 2018
Create Date August 14, 2018
Recall Status1 Terminated 3 on January 17, 2021
Recall Number Z-2794-2018
Recall Event ID 80552
510(K)Number K170891  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
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.
Code Information Lots #'s: 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643, and 195763A1.
Recalling Firm/
Manufacturer		 Mako Surgical Corporation
2555 Davie Rd Ste 110
Davie FL 33317-7424
For Additional Information Contact Mrs. Bethany Hinson
954-628-0598
Manufacturer Reason
for Recall		 Out of tolerance.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Stryker sent an Urgent Medical Device Removal letter dated May 14, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to sign the enclosed Recall Notification Business Reply Form and fax a copy to 1-855-741-4992 or email to strykerortho7035@stericycle.com.
Quantity in Commerce 10,606
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
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 Corp.
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