Mako Surgical Corporation: Medical Device Recall in 2017 - (Recall #: Z-1193-2017)

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:

Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.

Product Classification:

Class II

Date Initiated: September 29, 2016

Date Posted: February 22, 2017

Recall Number: Z-1193-2017

Event ID: 76025

Reason for Recall:

Failure of the Offset Cup Reamer Handle not engaging its mating components.

Status: Terminated

Product Quantity: 595 units

Code Information:

All lots recalled, Catalog No. 207080.

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, & WY and the countries of Italy, Germany, Australia, China, Europe, Hong Kong, South Africa, Germany, Thailand & Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated