Recall Z-1031-2016— Mako Surgical Corporation

Name: FDA recall Z-1031-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-15

Class II · Terminated

Class II FDA medical device recall by Mako Surgical Corporation, initiated 2016-01-15, terminated 2019-08-06. It names one FDA 510(k) clearance: K090763. Product: Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.. Reason: Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier..

Recalling firm: Mako Surgical Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-01-15
Terminated: 2019-08-06
Firm location: Plantation, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K090763 — RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMMako Surgical Corporation·cleared 2009-06-17

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

Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.

Reason for recall

Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.

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