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U.S. Department of Health and Human Services

Class 2 Device Recall Cable Assembly for the RIO STANDARD SYSTEM

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  Class 2 Device Recall Cable Assembly for the RIO STANDARD SYSTEM see related information
Date Initiated by Firm July 17, 2009
Date Posted October 19, 2009
Recall Status1 Terminated 3 on May 12, 2010
Recall Number Z-0064-2010
Recall Event ID 53033
510(K)Number K081867  
Product Classification Neurological Stereotaxic Instrument - Product Code HAW
Product 200996-Cable Assembly, Hybrid Extended Length,
200997 Cable Assembly, Hybrid, Guidance Module,
200998 Cable Assembly, Hybrid, UI Panel

Subcomponents for the 203000 RIO STANDARD SYSTEM

Manufactured by: MAKO Surgical, Corp. Fort Lauderdale, FL.

All three cables are integral components and are not purchased separately.
However, 200996-Cable Assembly is the only cable visible. This cable is labeled: 200996-REV-1, KSM 390634-1, SN 000001. 200997 and 200998 Cable Assembly are not visible .

The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Code Information Serial Numbers: ROB031 through ROB068.
Recalling Firm/
Manufacturer		 Mako Surgical Corporation
2555 Davie Rd Ste 110
Davie FL 33317-7424
For Additional Information Contact
954-927-2044 Ext. 605
Manufacturer Reason
for Recall		 Cables fail to provide adequate transmission. MAKO Surgical Corporation is recalling 200996 Cable Assembly, Hybrid Extended Length; 200997 Cable Assembly, Hybrid, Guidance Module; and 200998 Cable Assembly, Hybrid, UI Panel. These parts are sub components of the 20300 Rio Standard System.
FDA Determined
Cause 2		 Device Design
Action A Recall Notice, dated July 15, 2009, was sent to owners of the RIO system (hospital OR staff) with a signed acknowledgement returned to MAKO. Surgeons using the RIO system during the recall time period, regardless of whether their system has already been upgraded, are given the notification letter and asked to sign and return the acknowledgement memo. The letter stated that customers' RIO will be upgraded to replace the potentially faulty cable with a new cable. Their MAKOplasty Specialist (MPS) will notify them when their system was scheduled to have their fiber optic cable upgrade. The upgrade will be installed by a Field Service Engineer (FSE) free of charge and the RIO will be completely tested prior to being returned to service. Customers should direct questions or concerns to their MPS, FSE, or Jim Pomeroy, who can be reached at 954-927-2044.
Quantity in Commerce 23
Distribution Nationwide Distribution
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 = HAW and Original Applicant = MAKO SURGICAL CORP.
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