Skip to content
Recall Observatory FDA recall evidence

Device product

MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.

Z-1411-2017

December 22, 2016

Class II

Product summary

Firm
Mako Surgical Corporation
Event
Event 76158
Status
Terminated
Classification
Class II
Quantity
777
Official record key
device-enforcement:Z-1411-2017

Official wording

Reason: Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides

Code information: Part Item #: 204863 - THA 1.0 Application User Guide Part Item #: 207116 - THA 2.0 Application User Guide Part Item #: 208692 - THA 2.1 Application User Guide Part Item #: 209711 - MAKOplasty THA Application User Guide Part Item #: 210555 - MAKIplast THA 3.1 Application User Guide Part Item#: 212026 - THA Application User Guide 2.1-2.1.1 THA 3.0, THA 3.1, 3.1.1 and 3.1.1.1 Part Item # 204863 THA 1.0 Application User Guide Part Item # 207116 THA 2.0 Application User Guide Part Item # 208692 THA 2.1 Application User Guide Part Item # 209711 MAKOplasty THA Application User Guide Part Item # 210555 MAKIplast THA 3.1 Application User Guide Part Item # 212026 THA Application User Guide

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides