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U.S. Department of Health and Human Services

Class 2 Device Recall Makoplasty Partial Knee Application (PKA)

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 Class 2 Device Recall Makoplasty Partial Knee Application (PKA)see related information
Date Initiated by FirmAugust 07, 2017
Create DateSeptember 13, 2017
Recall Status1 Terminated 3 on August 06, 2019
Recall NumberZ-3130-2017
Recall Event ID 77950
510(K)NumberK112507 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductMakoplasty 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.
Code Information All 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
ActionThere will be no communication to the customer. Notification shall only go to the MAKO Product Specialist and Branch Managers as this action is not a customer facing issue. These letters and acknowledge forms were sent via Federal Express Two Days Air with return receipt.
Quantity in Commerce349 (US) and 78 (OUS)
DistributionWorldwide - 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
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OLO
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