MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
FDA Recall #Z-1411-2017 — Class II — December 22, 2016
Product Description
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Reason for Recall
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
Recalling Firm
Mako Surgical Corporation — Davie, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
777
Distribution
US nationwide distribution.
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated