Mako Surgical Corporation: Medical Device Recall in 2017 - (Recall #: Z-1411-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 22, 2016

Date Posted: March 15, 2017

Recall Number: Z-1411-2017

Event ID: 76158

Reason for Recall:

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

Status: Terminated

Product Quantity: 777

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.

Voluntary or Mandated:

Voluntary: Firm initiated