Mako Surgical Corporation: Medical Device Recall in 2016 - (Recall #: Z-1508-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Robotic Arm Interactive Orthopedic System (RIO)

Product Classification:

Class II

Date Initiated: April 30, 2014

Date Posted: April 27, 2016

Recall Number: Z-1508-2016

Event ID: 73202

Reason for Recall:

Revision of the field manual

Status: Terminated

Product Quantity: 249

Code Information:

Catalog # 203900 & 207092 All lots

Distribution Pattern:

Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Italy, Japan, Hong Kong, Scotland, Germany, Turkey , Greece, Singapore, Taiwan and South Korea.

Voluntary or Mandated:

Voluntary: Firm initiated