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U.S. Department of Health and Human Services

Class 2 Device Recall Robotic Arm Interactive Orthopedic System

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  Class 2 Device Recall Robotic Arm Interactive Orthopedic System see related information
Date Initiated by Firm April 30, 2014
Date Posted April 18, 2016
Recall Status1 Terminated 3 on July 24, 2019
Recall Number Z-1508-2016
Recall Event ID 73202
510(K)Number K121064  K112507  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Robotic Arm Interactive Orthopedic System (RIO)
Code Information Catalog # 203900 & 207092 All lots
Recalling Firm/
Manufacturer		 Mako Surgical Corporation
2555 Davie Rd Ste 110
Plantation FL 33317-7424
For Additional Information Contact Clayton Odor
866-647-6256
Manufacturer Reason
for Recall		 Revision of the field manual
FDA Determined
Cause 2		 Process control
Action As per our conversation with firm representative on March 23, 2016, they stated "no notification was sent to the customers", and referred to Ref: Part 806 File number: RA 2015-017 where it states "Stryker Orthopaedics has completed a retrospective review of other revisions to the field service manual, and we have confirmed there are no other similar events for which Part 806 reports should have been submitted". For further questions, please call (866) 647-6256. Internal actions taken only.
Quantity in Commerce 249
Distribution Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Italy, Japan, Hong Kong, Scotland, Germany, Turkey , Greece, Singapore, Taiwan and South Korea.
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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