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Recall Observatory FDA recall evidence

Device product

Makoplasty Partial Knee Application (PKA) 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.

Z-3130-2017

August 07, 2017

Class II

Product summary

Firm
Mako Surgical Corporation
Event
Event 77950
Status
Terminated
Classification
Class II
Quantity
349 (US) and 78 (OUS)
Official record key
device-enforcement:Z-3130-2017

Official wording

Reason: Software discrepancy of not showing all the EE constants, when the screen is filled.

Code information: All Lot codes

Distribution pattern: Worldwide - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY and the countries of Australia, Taiwan, China, Taiwan, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Ireland, Italy, Germany, India, Japan, Korea, Singapore, Thailand, Vietnam, South Africa, and Turkey

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Software discrepancy of not showing all the EE constants, when the screen is filled.