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Class 2 Device Recall MAKO RIO Standard System |
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Date Initiated by Firm |
June 07, 2017 |
Create Date |
July 18, 2017 |
Recall Status1 |
Terminated 3 on June 16, 2020 |
Recall Number |
Z-2741-2017 |
Recall Event ID |
77553 |
510(K)Number |
K112507
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Product Classification |
Orthopedic stereotaxic instrument - Product Code OLO
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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
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For Additional Information Contact |
Clayton Odor 954-628-0502
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Manufacturer Reason for Recall |
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
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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
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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.
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510(K) Database |
510(K)s with Product Code = OLO and Original Applicant = MAKO SURGICAL CORPORATION
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