Mako Surgical Corporation: Medical Device Recall in 2015 - (Recall #: Z-0224-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.

Product Classification:

Class II

Date Initiated: July 16, 2015

Date Posted: November 11, 2015

Recall Number: Z-0224-2016

Event ID: 72224

Reason for Recall:

The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.

Status: Terminated

Product Quantity: 1,322 units

Code Information:

Model/Catalog Numbers Affected: Mako Rio Robotic Arm (201000, 203999, 207300 and 209930. Lot/Serial Number: All RIO's.

Distribution Pattern:

Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and HI, and the countries of Italy, Japan, Hong Kong, Scotland, Germany, Turkey, Greece, Australia, Singapore, Taiwan, and South Korea.

Voluntary or Mandated:

Voluntary: Firm initiated