Recall Z-1193-2017— Mako Surgical Corporation

Name: FDA recall Z-1193-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-29

Class II · Terminated

Class II FDA medical device recall by Mako Surgical Corporation, initiated 2016-09-29, terminated 2019-08-06. It names one FDA 510(k) clearance: K121064. Product: 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.. Reason: Failure of the Offset Cup Reamer Handle not engaging its mating components..

Recalling firm: Mako Surgical Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-09-29
Terminated: 2019-08-06
Firm location: Davie, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K121064 — MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMMako Surgical Corporation·cleared 2012-06-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.