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U.S. Department of Health and Human Services

Class 2 Device Recall MAKO RIO Standard System

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  Class 2 Device Recall MAKO RIO Standard System see related information
Date Initiated by Firm June 07, 2017
Create Date July 18, 2017
Recall Status1 Open3, Classified
Recall Number Z-2741-2017
Recall Event ID 77553
510(K)Number K112507  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product MAKO RIO Standard System, internal cPCI Card CageP/N: 201337.

Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
Code Information Lot No. 05212015
Recalling Firm/
Manufacturer
Mako Surgical Corporation
2555 Davie Rd Ste 110
Davie FL 33317-7424
For Additional Information Contact Clayton Odor
954-628-0502
Manufacturer Reason
for Recall
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
FDA Determined
Cause 2
Employee error
Action Customers were sent notices titled "Urgent Medical Device Correction Notification" on 06/12/2017 via UPS Next Day Mail. The firm notifies consignees of the reason for recall and instructs that users of the recalled product be provided the recall notice. Users may continue to use their MAKO system; and, Stryker/MAKO Service personnel will contact users o schedule time to inspect and replace the card cage, if necessary. Also, users are instructed to return the completed Business Reply Form within 5 business days. The completed form can be sent to strykerortho7391@stericycle.com or faxed to 855-544-4807. Any questions can be directed to Clayton Odor at 954-628-0502.
Quantity in Commerce 20
Distribution Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = MAKO SURGICAL CORPORATION
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