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Recall Observatory FDA recall evidence

Device product

Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.

Z-0224-2016

July 16, 2015

Class II

Product summary

Firm
Mako Surgical Corporation
Event
Event 72224
Status
Terminated
Classification
Class II
Quantity
1,322 units
Official record key
device-enforcement:Z-0224-2016

Official wording

Reason: The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.

Code information: Model/Catalog Numbers Affected: Mako Rio Robotic Arm (201000, 203999, 207300 and 209930. Lot/Serial Number: All RIO's.

Distribution pattern: Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and HI, and the countries of Italy, Japan, Hong Kong, Scotland, Germany, Turkey, Greece, Australia, Singapore, Taiwan, and South Korea.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.