Reported Nov 28, 2012 · Terminated
The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing…
Mako Surgical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mako Surgical Corporation · 2555 Davie Rd Ste 110 · Plantation, FL · 33317-7424
Is this the product you have?
- 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 includeUnicondylar knee replacement (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA)
- Lot codes and dates
- ROB S/N GUD S/N CAM S/N
408 of 408 codes
ROB036GUD054CAM054ROB037GUD043CAM037ROB038GUD038CAM038ROB039GUD039CAM039ROB040GUD040CAM035ROB042GUD042CAM043ROB046GUD046CAM046ROB047GUD044CAM047ROB048GUD047CAM048ROB049GUD048CAM049ROB051GUD074CAM074ROB053GUD053CAM053ROB054GUD091CAM091ROB055GUD055CAM075ROB056GUD056CAM066ROB057GUD058CAM058ROB059GUD059CAM059ROB060GUD060CAM060ROB061GUD061CAM061ROB062GUD063CAM062
- ROB S/N GUD S/N CAM S/N
- Amount recalled
- 137 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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