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Recall Observatory FDA recall evidence

Device product

MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.

Z-2741-2017

June 07, 2017

Class II

Product summary

Firm
Mako Surgical Corporation
Event
Event 77553
Status
Terminated
Classification
Class II
Quantity
20
Official record key
device-enforcement:Z-2741-2017

Official wording

Reason: An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.

Code information: Lot No. 05212015

Distribution pattern: Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.