Mako THA and PKA Recall

Class 2 recall for Mako. Maybe think about hiring some better programers....

Class 2 Device Recall Total Hip Application (THA)
Date Initiated by FirmAugust 07, 2017
Create DateSeptember 13, 2017
Recall Status1Open3, Classified
Recall NumberZ-3131-2017
Recall Event ID77950
510(K)Number K121064 K141989
Product ClassificationOrthopedic stereotaxic instrument - Product Code OLO
ProductTotal Hip Application (THA)

Product Usage:
The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Code InformationAll Lot codes
Recalling Firm/
Manufacturer
Mako Surgical Corporation
2555 Davie Rd Ste 110
Davie FL 33317-7424
For Additional Information ContactClayton Odor
954-628-0502
Manufacturer Reason
for Recall
Software discrepancy of not showing all the EE constants, when the screen is filled.
FDA Determined
Cause 2
Software design

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A perfect example of why Silicon Valley is going to lead the charge in robotic surgery. Stryker is a sales and marketing company. Medical devices are becoming more software driven and Stryker has outsourced all of their IT. What do they know about software development and robotics?

Look at Medtronic's new Diabetes assistent product. The only way Medtronic could build that was because of their partnership with IBM. Medical Device companies don't have the talent in-house.

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A perfect example of why Silicon Valley is going to lead the charge in robotic surgery. Stryker is a sales and marketing company. Medical devices are becoming more software driven and Stryker has outsourced all of their IT. What do they know about software development and robotics?

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