Recall Z-0385-2013— Mako Surgical Corporation
Class II · Terminated
Class II FDA medical device recall by Mako Surgical Corporation, initiated 2012-09-12, terminated 2013-05-22. It names one FDA 510(k) clearance: K081867. Product: The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The 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 RIO is indicated for use in surgical knee and hip 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 (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA).. Reason: MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the system's software. Loss of tactile feedback constraining the cutting burr has been reported..
- Recalling firm
- Mako Surgical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-12
- Terminated
- 2013-05-22
- Firm location
- Plantation, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The 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 RIO is indicated for use in surgical knee and hip 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 (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA).
Reason for recall
MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the system's software. Loss of tactile feedback constraining the cutting burr has been reported.
Data sourced from openFDA. This site is unofficial and independent of the FDA.