Recall Z-1588-2016— Mako Surgical Corporation

Name: FDA recall Z-1588-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-25

Class II · Terminated

Class II FDA medical device recall by Mako Surgical Corporation, initiated 2015-11-25, terminated 2016-08-25. It names one FDA 510(k) clearance: K121064. Product: MAKOplasty Hip Array Kit Laminate 150230. Reason: Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table..

Recalling firm: Mako Surgical Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-11-25
Terminated: 2016-08-25
Firm location: Plantation, 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

MAKOplasty Hip Array Kit Laminate 150230

Reason for recall

Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.

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